Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital 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

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-06-30

Brief Summary

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To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of 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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Solithromycin (CEM-101)

A single oral dose of 1200 mg solithromycin

Group Type EXPERIMENTAL

solithromycin

Intervention Type DRUG

A single oral dose of 1200 mg solithromycin (CEM-101)

Solithromycin 1000 mg

A single oral dose of 1000 mg solithromycin

Group Type EXPERIMENTAL

Solithromycin (CEM-101)

Intervention Type DRUG

A single oral dose of 1000 mg solithromycin

Interventions

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solithromycin

A single oral dose of 1200 mg solithromycin (CEM-101)

Intervention Type DRUG

Solithromycin (CEM-101)

A single oral dose of 1000 mg solithromycin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
2. Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion.
3. Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria

1. Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis.
2. Known HIV, chronic hepatitis B, or hepatitis C infection.
3. Known concomitant infection which would require additional systemic antibiotics.
4. Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
5. Current use of corticosteroid drugs or other immunosuppressive therapy.
6. Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
7. Known significant renal, hepatic, or hematologic impairment.
8. History of intolerance or hypersensitivity to macrolide antibiotics.
9. Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g., life expectancy \<30 days).

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No