Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

Study Overview
=================
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.

Official 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

Conditions
-----------------
Uncomplicated Urogenital Gonorrhea

Intervention / Treatment
-----------------
* Drug: solithromycin
* Drug: ceftriaxone
* Drug: azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 1 of the following: 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. 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. 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ceftriaxone plus Azithromycin<br>A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin | Drug: ceftriaxone<br> <br> Drug: azithromycin<br> <br> |
| Experimental: Solithromycin<br>A single oral dose of 1000 mg solithromycin | Drug: solithromycin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 7 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days | 
| 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. |  | 7 days | 
| To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens. |  | 21 days after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gonorrhea, chlamydia, solithromycin