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

An Open-Label Study to Evaluate the Efficacy and Safety of a Single-Dose of Oral CEM-101 in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea

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

Study Overview

• Status: Completed
• Conditions: Uncomplicated Urogenital Gonorrhea
• Intervention / Treatment: Drug: solithromycin; Drug: Solithromycin (CEM-101)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Jefferson County Department of Health
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview STD Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solithromycin (CEM-101); A single oral dose of 1200 mg solithromycin	Drug: solithromycin; A single oral dose of 1200 mg solithromycin (CEM-101)
Experimental: Solithromycin 1000 mg; A single oral dose of 1000 mg solithromycin	Drug: Solithromycin (CEM-101); A single oral dose of 1000 mg solithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea	Adverse event reporting, clinical laboratory evaluations	One day after study drug dosing, and 3 to 9 days after study drug dosing
The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline)		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
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

Collaborators and Investigators

• Sponsor: Melinta Therapeutics, Inc.
• Investigators: Principal Investigator: Edward W Hook, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Hook EW 3rd, Golden M, Jamieson BD, Dixon PB, Harbison HS, Lowens S, Fernandes P. A Phase 2 Trial of Oral Solithromycin 1200 mg or 1000 mg as Single-Dose Oral Therapy for Uncomplicated Gonorrhea. Clin Infect Dis. 2015 Oct 1;61(7):1043-8. doi: 10.1093/cid/civ478. Epub 2015 Jun 18.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 4, 2012

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Gonorrhea; Anti-Infective Agents; Anti-Bacterial Agents; Solithromycin
• Other Study ID Numbers: CE01-202