Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea
This study is currently recruiting participants.
Verified May 2013 by Cempra Pharmaceuticals
Sponsor:
Cempra Pharmaceuticals
Information provided by (Responsible Party):
Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01591447
First received: May 2, 2012
Last updated: May 8, 2013
Last verified: May 2013
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Purpose
To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.
| Condition | Intervention | Phase |
|---|---|---|
|
Uncomplicated Urogenital Gonorrhea |
Drug: solithromycin Drug: Solithromycin (CEM-101) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cempra Pharmaceuticals:
Primary Outcome Measures:
- The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative [ Time Frame: 3 to 9 days after study drug dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea [ Time Frame: One day after study drug dosing, and 3 to 9 days after study drug dosing ] [ Designated as safety issue: Yes ]Adverse event reporting, clinical laboratory evaluations
- The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline) [ Time Frame: 3 to 9 days after study drug dosing ] [ Designated as safety issue: No ]
- Eradication or persistence of N. gonorrhoeae nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens [ Time Frame: 3 to 9 days after study drug dosing ] [ Designated as safety issue: No ]
- Eradication or persistence of Chlamydia trachomatis nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens [ Time Frame: 3 to 9 days after study drug dosing ] [ Designated as safety issue: No ]
- In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated [ Time Frame: Baseline and (if applicable) 3 to 9 days after study drug dosing ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 55 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
- Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms 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, arthritis, or endocarditis.
- Known HIV, chronic hepatitis B, or hepatitis C infection.
- Known concomitant infection which would require additional systemic antibiotics.
- Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
- Current use of corticosteroid drugs or other immunosuppressive therapy.
- Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
- Known significant renal, hepatic, or hematologic impairment.
- History of intolerance or hypersensitivity to macrolide antibiotics.
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591447
Contacts
| Contact: Kay Clark, MS | 919-313-6601 | kclark@cempra.com |
Locations
| United States, Alabama | |
| Jefferson County Department of Health | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Principal Investigator: Edward W Hook, MD | |
| United States, Washington | |
| Harborview STD Clinic | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Principal Investigator: Matthew Golden, MD | |
Sponsors and Collaborators
Cempra Pharmaceuticals
Investigators
| Principal Investigator: | Edward W Hook, MD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | Cempra Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01591447 History of Changes |
| Other Study ID Numbers: | CE01-202 |
| Study First Received: | May 2, 2012 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Gonorrhea Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial |
Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013