Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea
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ClinicalTrials.gov Identifier: NCT01591447 |
Recruitment Status :
Completed
First Posted : May 4, 2012
Last Update Posted : March 3, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uncomplicated Urogenital Gonorrhea | Drug: solithromycin Drug: Solithromycin (CEM-101) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Solithromycin (CEM-101)
A single oral dose of 1200 mg solithromycin
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Drug: solithromycin
A single oral dose of 1200 mg solithromycin (CEM-101) |
Experimental: Solithromycin 1000 mg
A single oral dose of 1000 mg solithromycin
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Drug: Solithromycin (CEM-101)
A single oral dose of 1000 mg solithromycin |
- 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 ]
- 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 ]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 ]
- 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 ]
- 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 ]
- In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated [ Time Frame: Baseline and (if applicable) 3 to 9 days after study drug dosing ]

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591447
United States, Alabama | |
Jefferson County Department of Health | |
Birmingham, Alabama, United States, 35233 | |
United States, Washington | |
Harborview STD Clinic | |
Seattle, Washington, United States, 98104 |
Principal Investigator: | Edward W Hook, MD | University of Alabama at Birmingham |
Responsible Party: | Melinta Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT01591447 |
Other Study ID Numbers: |
CE01-202 |
First Posted: | May 4, 2012 Key Record Dates |
Last Update Posted: | March 3, 2017 |
Last Verified: | March 2017 |
Gonorrhea Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Communicable Diseases Solithromycin Anti-Bacterial Agents Anti-Infective Agents |