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

Uncomplicated Urogenital Gonorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591447
• Other study ID #: CE01-202
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2012
• Last updated: March 1, 2017
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: March 2017
• Source: Cempra Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Gonorrhea
• Uncomplicated Urogenital Gonorrhea

Intervention

Drug:
• solithromycin
A single oral dose of 1200 mg solithromycin (CEM-101)
• Solithromycin (CEM-101)
A single oral dose of 1000 mg solithromycin

Locations

Country	Name	City	State
United States	Jefferson County Department of Health	Birmingham	Alabama
United States	Harborview STD Clinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Cempra Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline)		3 to 9 days after study drug dosing
Secondary	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
Secondary	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
Secondary	In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated		Baseline and (if applicable) 3 to 9 days after study drug dosing