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

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:

MedlinePlus related topics: Gonorrhea

U.S. FDA Resources

Further study details as provided by Cempra Inc:

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 ]


Enrollment:	60
Study Start Date:	May 2012
Study Completion Date:	June 2013
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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591447

Locations


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

Sponsors and Collaborators

Cempra Inc

Investigators


Principal Investigator:	Edward W Hook, MD	University of Alabama at Birmingham

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Cempra Inc
ClinicalTrials.gov Identifier:	NCT01591447 History of Changes
Other Study ID Numbers:	CE01-202
Study First Received:	May 2, 2012
Last Updated:	February 6, 2014
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 September 27, 2016