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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04010539
Registration number
NCT04010539
Ethics application status
Date submitted
2/07/2019
Date registered
8/07/2019
Date last updated
30/05/2024
Titles & IDs
Public title
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
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Scientific title
A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
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Secondary ID [1]
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2018-001780-23
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Secondary ID [2]
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116577
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gonorrhea
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Condition category
Condition code
Infection
0
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0
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Sexually transmitted infections
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Reproductive Health and Childbirth
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Gepotidacin
Treatment: Drugs - Ceftriaxone
Treatment: Drugs - Azithromycin
Experimental: Participants receiving Gepotidacin - Participants will receive Gepotidacin orally at the study site during the Baseline (Day 1) visit followed by self-administration of a second oral dose as an outpatient 10 to 12 hours after the first dose.
Active Comparator: Participants receiving Ceftriaxone plus Azithromycin - Participants will receive a single IM dose of Ceftriaxone plus a single oral dose of Azithromycin at the study site during the Baseline (Day 1) visit.
Treatment: Drugs: Gepotidacin
Gepotidacin will be administered as 3000 milligram (mg) oral dose (4 X 750 mg tablets) at the study site followed by 3000 mg oral dose (4 X 750 mg tablets) as an outpatient. Each dose should be taken after food consumption and with water.
Treatment: Drugs: Ceftriaxone
Ceftriaxone is available as sterile powder for reconstitution. It will be administered as one 500-mg IM dose at the study site.
Treatment: Drugs: Azithromycin
Azithromycin will be administered as 1000 mg oral dose (2 X 500 mg tablets) at the study site. Dose should be taken after food consumption and with water.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8)
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Assessment method [1]
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Urogenital specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
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Timepoint [1]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [1]
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Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit
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Assessment method [1]
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Rectal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
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Timepoint [1]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [2]
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Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit
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Assessment method [2]
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Pharyngeal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
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Timepoint [2]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [3]
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Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs)
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Assessment method [3]
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
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Timepoint [3]
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Up to 21 days
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Secondary outcome [4]
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
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Assessment method [4]
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Blood samples were collected for the assessment of change from baseline in hematology parameters: basophils, eosinophil, leukocytes, neutrophils, platelets, lymphocytes, monocytes, neutrophils and nucleated erythrocytes. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [4]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [5]
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Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
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Assessment method [5]
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Blood samples were collected for the assessment of change from baseline in hematology parameters: mean corpuscular hemoglobin concentration and hemoglobin. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [5]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [6]
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Change From Baseline in Hematology Parameter: Hematocrit
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Assessment method [6]
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Blood samples were collected for the assessment of change from baseline in hematology parameter: hematocrit. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [6]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [7]
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Change From Baseline in Hematology Parameter: Erythrocytes
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Assessment method [7]
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Blood samples were collected for the assessment of change from baseline in hematology parameter: red blood cell (RBC) count. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [7]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [8]
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Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
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Assessment method [8]
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Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular hemoglobin (MCH). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [8]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [9]
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Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
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Assessment method [9]
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Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular volume (MCV). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [9]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [10]
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Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
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Assessment method [10]
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Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: urea nitrogen (UN), glucose, calcium, chloride, sodium, magnesium and potassium. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [10]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [11]
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Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
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Assessment method [11]
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Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: bilirubin, direct bilirubin and creatinine levels. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [11]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [12]
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Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
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Assessment method [12]
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Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: albumin and protein. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [12]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [13]
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Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)
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Assessment method [13]
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Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [13]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [14]
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Number of Participants With Urinalysis Dipstick Results
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Assessment method [14]
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Urine samples were collected for urinalysis: Glucose, Protein, Occult Blood and Ketones. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Small, Moderate, Large, Positive, 5 milligram per deciliter (mg/dL), 20 mg/dL, 30 mg/dL 50 mg/dL, 100 mg/dL, 150 mg/dL and >=500 mg/dL indicating concentrations in the urine sample. In the row title (Glucose, Baseline, Negative), Glucose indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [14]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [15]
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Absolute Values in Specific Gravity of Urine
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Assessment method [15]
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Urine samples were collected from participants to assess urine specific gravity. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [15]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [16]
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Absolute Values in Potential of Hydrogen (pH) of Urine
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Assessment method [16]
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Urine samples were collected from participants to assess urine pH. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [16]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [17]
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Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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Assessment method [17]
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SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [17]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [18]
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Change From Baseline in Vital Sign: Pulse Rate
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Assessment method [18]
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Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [18]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Secondary outcome [19]
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Change From Baseline in Vital Sign: Temperature
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Assessment method [19]
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Temperature was measured after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
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Timepoint [19]
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Baseline (Day 1) and TOC visit (Day 4 to 8)
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Eligibility
Key inclusion criteria
- Participants must be >=12 years of age at the time of signing the informed consent.
- Participants having body weight of >45 kilogram (kg).
- Participants having clinical suspicion of a urogenital gonococcal infection with or
without pharyngeal and/or rectal gonococcal infection and have one of the following:
male participants with purulent yellow, green, or white urethral discharge or female
participants with abnormal cervical or vaginal mucopurulent discharge upon physical
examination; or a prior positive culture for N. gonorrhoeae from up to 5 days before
screening (as long as the participant has not received any treatment for this
infection); or a Gram or equivalent stain (urogenital specimens only) positive or
presumptive for Gram-negative intracellular diplococci from up to 5 days before
screening (as long as the participant has not received any treatment for this
infection); or a prior positive nucleic acid amplification test assay for N.
gonorrhoeae from up to 7 days before screening (as long as the participant has not
received any treatment for this infection).
- Participants who are willing to avoid anal, oral, and vaginal sexual intercourse or
use condoms for all forms of intercourse from the Baseline Visit through the TOC
Visit.
- Male or female participants having his or her original urogenital anatomy at birth.
- Male participant must agree to use contraception (male condoms) during intercourse
from the Baseline Visit through completion of the TOC Visit.
- Female participant is eligible to participate if she is not pregnant, not
breastfeeding, and at least 1 of the following conditions applies: Not a woman of
childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive
guidance (male partners of WOCBP must use a male condom during intercourse) from the
Baseline Visit through completion of the TOC Visit.
- Participants who are capable of giving signed informed consent or assent, which
includes compliance with the requirements and restrictions listed in the informed
consent form (ICF) or assent form and in study protocol.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Male participants with a current diagnosis of epididymitis and/or orchitis at the time
of the Baseline Visit.
- Participant who is suspected or confirmed to have a Chlamydia trachomatis infection
and per the investigator's judgement standard-of-care treatment for this infection
cannot be safely postponed until the TOC Visit.
- Participant has a body mass index >=40 kilogram per square meter (kg/m^2) or has a
body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions
such as high blood pressure or diabetes.
- Participant has a history of sensitivity to the study treatments, or components
thereof, or a history of a drug (including erythromycin and any macrolide or ketolide
drug) or other allergy that, in the opinion of the investigator or medical monitor,
contraindicates his or her participation.
- Participant is immunocompromised or has altered immune defenses that may predispose
the participant to a higher risk of treatment failure and/or complications.
- Participants with a known cluster of differentiation 4 (CD4) count of <200 cells per
cubic millimeter (cells/mm^3).
- Participant has any of the following: poorly controlled asthma or chronic obstructive
pulmonary disease, acute severe pain, uncontrolled with conventional medical
management, active peptic ulcer disease, Parkinson disease, Myasthenia gravis, a
history of seizure disorder requiring medications for control or participant has any
surgical or medical condition that may interfere with drug absorption, distribution,
metabolism, or excretion of the study treatment.
- Participant has known anuria, oliguria, or severe impairment of renal function
(creatinine clearance <30 milliliter per minute [mL/min] or clinically significant
elevated serum creatinine as determined by the investigator).
- Participant in the judgment of the investigator, would not be able or willing to
comply with the protocol or complete study follow-up.
- Participant has a serious underlying disease that could be imminently life
threatening, or the participant is unlikely to survive for the duration of the study
period.
- Participant has congenital long QT syndrome or known prolongation of corrected QT
interval (QTc).
- Participant has uncompensated heart failure.
- Participant has severe left ventricular hypertrophy.
- Participant has a family history of QT prolongation or sudden death.
- Participant has a recent history of vasovagal syncope or episodes of symptomatic
bradycardia or bradyarrhythmia within the last 12 months.
- The participant is taking QT-prolonging drugs or drugs known to increase the risk of
torsades de pointes (TdP) per the www.crediblemeds.org "Known Risk of TdP" category at
the time of his or her Baseline Visit, which cannot be safely discontinued from the
Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450
enzyme 3A4 (CYP3A4) inhibitor or a strong P-glycoprotein (P-gp) inhibitor.
- For any participant >=12 to <18 years, the participant has an abnormal
electrocardiogram (ECG) reading.
- The participant has a QTc >450 millisecond (msec) or a QTc >480 msec for participants
with bundle-branch block.
- Participant has a documented or recent history of uncorrected hypokalemia within the
past 3 months.
- Participant has a known history of cholestatic jaundice or hepatic dysfunction
associated with prior use of azithromycin.
- Participant has a known alanine aminotransferase (ALT) value >2 times upper limit of
normal (ULN).
- Participant has a known bilirubin value >1.5 times ULN (isolated bilirubin >1.5 times
ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Participant has a current or chronic history of liver disease, or known hepatic or
biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic
gallstones), including symptomatic viral hepatitis or moderate-to-severe liver
insufficiency (Child Pugh class B or C).
- Participant has been previously randomized in this study or has previously been
treated with Gepotidacin.
- Participant has participated in a clinical trial and has received an investigational
product within 30 days or 5 half-lives, whichever is longer.
- Participant has any of the following gonococcal infections that require a different
dose or duration of treatment: suspected or confirmed pelvic inflammatory disease; or
suspected or confirmed gonococcal arthritis; or suspected or confirmed gonococcal
conjunctivitis; or suspected or confirmed gonococcal endocarditis; or other evidence
of disseminated gonococcal infection.
- Participant has received any antibacterial therapy for the treatment of a gonococcal
infection within 14 days before the Baseline Visit.
- Participant has received any systemic, topical, or intravaginal antibiotics or any
systemic antifungals within 7 days before the Baseline Visit.
- Participant must not use St John's wort or ergot derivatives from within 14 days
before the Baseline Visit through the TOC Visit.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/10/2023
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Sample size
Target
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Accrual to date
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Final
628
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Darlinghurst, Sydney
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Recruitment hospital [2]
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GSK Investigational Site - Darlinghurst
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Recruitment hospital [3]
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GSK Investigational Site - Southport
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Recruitment hospital [4]
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GSK Investigational Site - Carlton
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Recruitment hospital [5]
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GSK Investigational Site - Prahran
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Recruitment postcode(s) [1]
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2010 - Darlinghurst, Sydney
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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3053 - Carlton
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Recruitment postcode(s) [5]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Georgia
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Indiana
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Louisiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Massachusetts
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Country [7]
0
0
United States of America
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State/province [7]
0
0
North Carolina
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Ohio
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Texas
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Country [10]
0
0
Germany
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State/province [10]
0
0
Bayern
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Country [11]
0
0
Germany
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State/province [11]
0
0
Hessen
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Country [12]
0
0
Germany
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State/province [12]
0
0
Nordrhein-Westfalen
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Country [13]
0
0
Germany
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State/province [13]
0
0
Berlin
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Country [14]
0
0
Germany
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State/province [14]
0
0
Hamburg
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Country [15]
0
0
Germany
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State/province [15]
0
0
München
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Country [16]
0
0
Mexico
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State/province [16]
0
0
Jalisco
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Country [17]
0
0
Mexico
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State/province [17]
0
0
Monterrey
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Country [18]
0
0
Spain
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State/province [18]
0
0
Barcelona
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Country [19]
0
0
Spain
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State/province [19]
0
0
Bilbao
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Country [20]
0
0
Spain
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State/province [20]
0
0
Madrid
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Country [21]
0
0
Spain
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State/province [21]
0
0
Sevilla
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Country [22]
0
0
United Kingdom
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State/province [22]
0
0
Birmingham
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Country [23]
0
0
United Kingdom
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State/province [23]
0
0
Brighton
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Country [24]
0
0
United Kingdom
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State/province [24]
0
0
Edinburgh
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Country [25]
0
0
United Kingdom
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State/province [25]
0
0
Leeds
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Country [26]
0
0
United Kingdom
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State/province [26]
0
0
London
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Country [27]
0
0
United Kingdom
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State/province [27]
0
0
Manchester
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Country [28]
0
0
United Kingdom
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State/province [28]
0
0
Reading
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Country [29]
0
0
United Kingdom
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State/province [29]
0
0
St Helens
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Summary
Brief summary
This is a phase III, randomized, multicenter, open-label study which will be performed to
evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone
plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by
Neisseria gonorrhoeae (N. gonorrhoeae) in adolescent and adult participants. In this study,
participants will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone
plus oral azithromycin.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04010539
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04010539
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