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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01591447
First received: May 2, 2012
Last updated: February 6, 2014
Last verified: February 2014

May 2, 2012
February 6, 2014
May 2012
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01591447 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uncomplicated Urogenital Gonorrhea
  • Drug: solithromycin
    A single oral dose of 1200 mg solithromycin (CEM-101)
  • Drug: Solithromycin (CEM-101)
    A single oral dose of 1000 mg solithromycin
  • Experimental: Solithromycin (CEM-101)
    A single oral dose of 1200 mg solithromycin
    Intervention: Drug: solithromycin
  • Experimental: Solithromycin 1000 mg
    A single oral dose of 1000 mg solithromycin
    Intervention: Drug: Solithromycin (CEM-101)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2013
June 2013   (final data collection date for primary outcome measure)

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).
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01591447
CE01-202
No
Cempra Pharmaceuticals
Cempra Pharmaceuticals
Not Provided
Principal Investigator: Edward W Hook, MD University of Alabama at Birmingham
Cempra Pharmaceuticals
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP