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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-02-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Uncomplicated Urogenital Gonorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ceftriaxone plus Azithromycin

A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin

Group Type ACTIVE_COMPARATOR

ceftriaxone

Intervention Type DRUG

azithromycin

Intervention Type DRUG

Solithromycin

A single oral dose of 1000 mg solithromycin

Group Type EXPERIMENTAL

solithromycin

Intervention Type DRUG

Interventions

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solithromycin

Intervention Type DRUG

ceftriaxone

Intervention Type DRUG

azithromycin

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No