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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/NCT05630833
Registration number
NCT05630833
Ethics application status
Date submitted
23/11/2022
Date registered
30/11/2022
Date last updated
10/02/2023
Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
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Scientific title
A Phase III, Multicenter, Randomized, Active Reference, Double Blind, Double-dummy Study in Japanese Female Participants to Evaluate the Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
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Secondary ID [1]
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214144
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Universal Trial Number (UTN)
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Trial acronym
EAGLE-J
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Infection
0
0
0
0
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Studies of infection and infectious agents
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Infection
0
0
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0
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Other infectious diseases
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Infection
0
0
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0
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Sexually transmitted infections
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Renal and Urogenital
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0
0
0
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Other renal and urogenital disorders
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Inflammatory and Immune System
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0
0
0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Gepotidacin
Treatment: Drugs - Nitrofurantoin
Treatment: Drugs - Placebo
Experimental: Gepotidacin + Placebo -
Active Comparator: Nitrofurantoin + Placebo -
Treatment: Drugs: Gepotidacin
Gepotidacin will be administered.
Treatment: Drugs: Nitrofurantoin
Nitrofurantoin will be administered.
Treatment: Drugs: Placebo
Placebo will be administered.
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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 therapeutic response (combined per participant clinical and microbiological response) at the TOC Visit
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Assessment method [1]
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A therapeutic success refers to participants who have been deemed both a "microbiological success" (reduction of all qualifying bacterial uropathogens [greater than or equal to {>=}10^5 colony-forming units per milliliter {CFU/mL}] recovered at Baseline to less than (<)10^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials at the TOC Visit) and a "clinical success" (resolution of signs and symptoms of acute cystitis present at Baseline [and no new signs and symptoms] without the participant receiving other systemic antimicrobials at the TOC Visit). All other combinations (other than clinical success + microbiological success) are deemed failures for therapeutic response.
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Timepoint [1]
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Days 10 to 13
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Secondary outcome [1]
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Number of participants with therapeutic response to gepotidacin compared to nitrofurantoin at the TOC Visit
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Assessment method [1]
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0
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Timepoint [1]
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Days 10 to 13
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Secondary outcome [2]
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Number of participants with clinical outcome and response at the TOC visit
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Assessment method [2]
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Clinical success (response) is defined as clinical resolution. Clinical resolution (outcome) is defined as resolution of signs and symptoms of acute cystitis present at Baseline (and no new signs and symptoms) without the participant receiving other systemic antimicrobials.
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Timepoint [2]
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Days 10 to 13
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Secondary outcome [3]
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Number of participants with per participant microbiological outcome and response at the TOC visit
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Assessment method [3]
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Participant-level microbiological success (response) is defined as microbiological eradication. Microbiological eradication (outcome) is defined as reduction of all qualifying bacterial uropathogens [>=10^5 CFU/mL] recovered at Baseline to <10^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials.
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Timepoint [3]
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Days 10 to 13
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Secondary outcome [4]
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Number of participants with therapeutic response in female participants with acute uncomplicated cystitis who have qualifying uropathogen(s) resistant to two or more specific classes of antimicrobials
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Assessment method [4]
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Timepoint [4]
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Days 10 to 13
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Secondary outcome [5]
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Number of participants with clinical outcome and response in female participants with acute uncomplicated cystitis who have qualifying uropathogen(s) resistant to two or more specific classes of antimicrobials
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Assessment method [5]
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Timepoint [5]
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Days 10 to 13
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Secondary outcome [6]
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Number of participants with microbiological outcome and response in female participants with acute uncomplicated cystitis who have qualifying uropathogen(s) resistant to two or more specific classes of antimicrobials
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Assessment method [6]
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0
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Timepoint [6]
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Days 10 to 13
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Secondary outcome [7]
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Number of participants with Investigator assessment of clinical response at the TOC Visit
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Assessment method [7]
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Timepoint [7]
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Days 10 to 13
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Secondary outcome [8]
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Number of participants with Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [8]
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Timepoint [8]
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Up to Day 31
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Secondary outcome [9]
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Number of participants with Serious Adverse Events (SAEs)
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Assessment method [9]
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Timepoint [9]
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Up to Day 31
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Secondary outcome [10]
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Number of participants with Adverse Events of Special Interest (AESIs)
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Assessment method [10]
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Timepoint [10]
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Up to Day 31
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Secondary outcome [11]
0
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Change from baseline in hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count (Giga cells per liter)
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Assessment method [11]
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Timepoint [11]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [12]
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Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per liter)
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Assessment method [12]
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Timepoint [12]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [13]
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Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per liter)
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Assessment method [13]
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Timepoint [13]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [14]
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Change from baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)
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Assessment method [14]
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Timepoint [14]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [15]
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Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
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Assessment method [15]
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Timepoint [15]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [16]
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Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms)
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Assessment method [16]
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Timepoint [16]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [17]
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Change from baseline in clinical chemistry parameters: Blood urea nitrogen [BUN], glucose [non-fasting], calcium, chloride, sodium, magnesium, phosphate, and potassium levels (Millimoles per liter)
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Assessment method [17]
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Timepoint [17]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [18]
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Change from baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per liter)
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Assessment method [18]
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Timepoint [18]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [19]
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Change from baseline in clinical chemistry parameters: albumin and total protein levels (Gram per liter)
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Assessment method [19]
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Timepoint [19]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [20]
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Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels (International units per liter)
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Assessment method [20]
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Timepoint [20]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [21]
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Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg])
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Assessment method [21]
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Timepoint [21]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [22]
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Change from baseline in pulse rate (Beats per minute)
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Assessment method [22]
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Timepoint [22]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [23]
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Change from baseline in body temperature (Degrees Celsius)
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Assessment method [23]
0
0
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Timepoint [23]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [24]
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Change from baseline in heart rate (Beats per minute)
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Assessment method [24]
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0
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Timepoint [24]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [25]
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Change from baseline in electrocardiogram parameters: PR Interval, QRS Duration, QT Interval, QT interval corrected for heart rate according Fridericia's formula (QTcF) and Bazett's formula (QTcB) (Milliseconds [msec])
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Assessment method [25]
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0
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Timepoint [25]
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Baseline, On-Therapy (Days 2 to 4), and TOC (Days 10 to 13)
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Secondary outcome [26]
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Plasma concentration of gepotidacin
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Assessment method [26]
0
0
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Timepoint [26]
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Up to Day 4
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Secondary outcome [27]
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Urine concentration of gepotidacin
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Assessment method [27]
0
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Timepoint [27]
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Up to Day 4
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Eligibility
Key inclusion criteria
- The participant has a body weight >=40 kilograms (kg).
- The participant has 2 or more of the following clinical signs and symptoms of acute
cystitis with onset less than (<) 96 hours prior to study entry: dysuria, frequency,
urgency, or lower abdominal pain.
- The participant has nitrite or pyuria (greater than [>]15 white blood cell
[WBC]/high-power field [HPF] or the presence of 3 plus (+) /large leukocyte esterase)
from a pretreatment clean-catch midstream urine sample based on local laboratory
procedures.
- The participant is capable of giving signed informed consent/assent.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- The participant resides in a nursing home or dependent care type facility.
- The participant has a body mass index >=40.0 kilogram per meter square (kg/m^2) or a
body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions
such as uncontrolled high blood pressure or uncontrolled diabetes.
- The participant is immunocompromised or has altered immune defenses that may
predispose the participant to a higher risk of treatment failure and/or complications.
- The participant has any of the following:
- Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe
pain; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; a
history of seizure disorder requiring medications for control (this does not
include a history of childhood febrile seizures); Or
- Known acute porphyria.
- Any surgical or medical condition (active or chronic) that may interfere with
drug absorption, distribution, metabolism, or excretion of the study
intervention.
- The participant has a known glucose-6-phosphate dehydrogenase deficiency.
- The participant, in the judgment of the investigator, would not be able or willing to
comply with the protocol or complete study follow-up.
- The participant has acute uncomplicated cystitis that is known or suspected to be due
to fungal, parasitic, or viral pathogens; or known or suspected to be due to
Pseudomonas aeruginosa or Enterobacterales (other than E. coli) as the contributing
pathogen.
- The participant has symptoms known or suspected to be caused by another disease
process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence,
or chronic interstitial cystitis, that may interfere with the clinical efficacy
assessments or preclude complete resolution of acute cystitis symptoms.
- The participant has an anatomical or physiological anomaly that predisposes the
participant to UTIs or may be a source of persistent bacterial colonization, including
calculi, obstruction or stricture of the urinary tract, primary renal disease (e.g.,
polycystic renal disease), or neurogenic bladder, or the participant has a history of
anatomical or functional abnormalities of the urinary tract (e.g., chronic
vesicoureteral reflux, detrusor insufficiency).
- The participant has an indwelling catheter, nephrostomy, ureter stent, or other
foreign material in the urinary tract.
- The participant who, in the opinion of the investigator, has an otherwise complicated
UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptom onset
>=96 hours before study entry, or a temperature >=38 Degrees Celsius [°C], flank pain,
chills, or any other manifestations suggestive of upper UTI.
- The participant has known anuria, oliguria, or significant impairment of renal
function (creatinine clearance <60 milliliters per minute (mL/min) or clinically
significant elevated serum creatinine as determined by the investigator).
- The participant presents with vaginal discharge at Baseline (e.g., suspected sexually
transmitted disease).
- The participant has congenital long QT syndrome or known prolongation of the corrected
QT (QTc) interval.
- The participant has uncompensated heart failure.
- The participant has severe left ventricular hypertrophy.
- The participant has a family history of QT prolongation or sudden death.
- The participant has a recent history of vasovagal syncope or episodes of symptomatic
bradycardia or brady arrhythmia 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 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.
- For any participant >=12 to <18 years of age, the participant has an abnormal ECG
reading at Baseline.
- The participant has a QTc >450 msec or a QTc >480 msec for participants with bundle
branch block.
- The participant has a documented or recent history of uncorrected hypokalemia within
the past 3 months.
- The participant has a known alanine aminotransferase (ALT) value >2 times upper limit
of normal (ULN).
- The participant has a known total bilirubin value >1.5 times ULN (isolated bilirubin
>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35
percent [%]).
- The participant has cirrhosis or current unstable liver or biliary disease per
investigator assessment defined by the presence of ascites, encephalopathy,
coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice.
- The participant has a previous history of cholestatic jaundice/hepatic dysfunction
associated with nitrofurantoin.
- The participant has received treatment with other systemic antimicrobials or systemic
antifungals within 1 week before study entry.
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
Recruiting
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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
11/01/2023
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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
9/10/2023
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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0
Japan
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State/province [1]
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Ibaraki
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Country [2]
0
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Japan
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State/province [2]
0
0
Osaka
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Country [3]
0
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Japan
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State/province [3]
0
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Saitama
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin at the Test of cure (TOC) Visit (Days 10 to 13) in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 [NCT04020341] and 212390 [NCT04187144]).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05630833
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
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Address
0
0
GlaxoSmithKline
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
US GSK Clinical Trials Call Center
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Address
0
0
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Country
0
0
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Phone
0
0
877-379-3718
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT05630833
Download to PDF