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

Phase 2

Completed

• Conditions: Uncomplicated Urogenital Gonorrhea
• Interventions: Drug: Solithromycin (CEM-101); Drug: solithromycin

• Registration Number: NCT01591447
• Lead Sponsor: Melinta Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Disposition First Submitted: 2014-02-06
• Disposition First Submitted QC: 2014-02-06
• Disposition First Posted: 2014-03-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solithromycin 1000 mg	Solithromycin (CEM-101)	A single oral dose of 1000 mg solithromycin
Solithromycin (CEM-101)	solithromycin	A single oral dose of 1200 mg solithromycin

Primary Outcome Measures

Name	Time	Method
The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative	3 to 9 days after study drug dosing

Secondary Outcome Measures

Name	Time	Method
The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline)	3 to 9 days after study drug dosing
Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea	One day after study drug dosing, and 3 to 9 days after study drug dosing	Adverse event reporting, clinical laboratory evaluations
Eradication or persistence of Chlamydia trachomatis nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens	3 to 9 days after study drug dosing
In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated	Baseline and (if applicable) 3 to 9 days after study drug dosing
Eradication or persistence of N. gonorrhoeae nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens	3 to 9 days after study drug dosing

Trial Locations

Locations (2)

Harborview STD Clinic; 🇺🇸 Seattle, Washington, United States

Jefferson County Department of Health; 🇺🇸 Birmingham, Alabama, United States