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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - Adverse event frequency and severity will be compared between patients who received solithromycin and those who received ceftriaxone plus azithromycin
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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
Other publications