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Trial record 1 of 1 for:    NCT01591447
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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
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 2, 2012
First Posted Date  ICMJE May 4, 2012
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE May 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea
Official Title  ICMJE 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
Brief Summary To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uncomplicated Urogenital Gonorrhea
Intervention  ICMJE
  • Drug: solithromycin
    A single oral dose of 1200 mg solithromycin (CEM-101)
  • Drug: Solithromycin (CEM-101)
    A single oral dose of 1000 mg solithromycin
Study Arms  ICMJE
  • 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)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2013)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2012)
30
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591447
Other Study ID Numbers  ICMJE CE01-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melinta Therapeutics, Inc.
Study Sponsor  ICMJE Melinta Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward W Hook, MD University of Alabama at Birmingham
PRS Account Melinta Therapeutics, Inc.
Verification Date March 2017

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