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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/NCT02210325




Registration number
NCT02210325
Ethics application status
Date submitted
1/08/2014
Date registered
6/08/2014
Date last updated
11/09/2017

Titles & IDs
Public title
Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
Scientific title
An Open-Label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of Oral Solithromycin Compared to Single-Dose Intramuscular Ceftriaxone Plus Single-Dose Oral Azithromycin in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea With or Without Concomitant Chlamydia
Secondary ID [1] 0 0
15-0091, HHSN272201300013
Secondary ID [2] 0 0
CE01-302
Universal Trial Number (UTN)
Trial acronym
SOLITAIRE-U
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated Urogenital Gonorrhea 0 0
Condition category
Condition code
Infection 0 0 0 0
Sexually transmitted infections
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - solithromycin
Treatment: Drugs - ceftriaxone
Treatment: Drugs - azithromycin

Active Comparator: Ceftriaxone plus Azithromycin - A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin

Experimental: Solithromycin - A single oral dose of 1000 mg solithromycin


Treatment: Drugs: solithromycin


Treatment: Drugs: ceftriaxone


Treatment: Drugs: azithromycin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population.
Timepoint [1] 0 0
7 days after treatment
Secondary outcome [1] 0 0
To assess the safety and tolerability of a single oral dose of solithromycin compared to single-dose IM ceftriaxone plus single-dose oral azithromycin in patients with gonorrhea
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
To compare bacterial eradication rates of N. gonorrhoeae from rectal or pharyngeal cultures following a single dose of oral solithromycin compared to single-dose IM ceftriaxone plus oral azithromycin.
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens.
Timepoint [3] 0 0
21 days after treatment

Eligibility
Key inclusion criteria
- At least 1 of the following:

1. Untreated male with urethral gonorrhea as determined by a screening laboratory
test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study
drug administration.

2. Untreated female with cervical gonorrhea as determined by a screening laboratory
test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study
drug administration.

3. Urethral (male) or cervical (female) Gram stain demonstrating Gram-negative
intracellular diplococci and leukocytes.

- The patient must be willing to abstain from anal, oral, and vaginal sexual intercourse
or use condoms for all of these until study completion.

- Females of childbearing potential (including females less than 2 years
post-menopausal) must have a negative pregnancy test at enrollment.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Confirmed or suspected complicated or systemic gonococcal infections such as pelvic
inflammatory disease, epididymitis, arthritis, endocarditis, or disseminated
gonococcal infection.

- Individuals who have already received antibiotic treatment for their gonorrhea.

- Use of systemic or intravaginal antibiotics within 7 days prior to study drug
administration.

- Women who are pregnant or nursing.

- Men with suspected or confirmed rectal gonorrhea and symptoms of proctitis.

- History of significant intolerance or allergy to macrolide or cephalosporin
antibiotics.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/02/2017
Sample size
Target
Accrual to date
Final
264
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
3053 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Melinta Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Allergy and Infectious Diseases (NIAID)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare a single dose of oral solithromycin to the standard of care
(intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with
urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin
resulted in 100% microbiological eradication in male and female patients with uncomplicated
urogenital gonorrhea.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02210325
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marcus Chen, MD, PhD
Address 0 0
Melbourne Sexual Health Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02210325