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Clinical Trials/NCT01591447
NCT01591447CompletedPhase 2

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

Melinta Therapeutics, Inc.2 sites in 1 country60 target enrollmentStarted: May 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
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).

Arms & Interventions

Solithromycin (CEM-101)

Experimental

A single oral dose of 1200 mg solithromycin

Intervention: solithromycin (Drug)

Solithromycin 1000 mg

Experimental

A single oral dose of 1000 mg solithromycin

Intervention: Solithromycin (CEM-101) (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea(One day after study drug dosing, and 3 to 9 days after study drug dosing)
  • The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline)(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(3 to 9 days after study drug dosing)
  • In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated(Baseline and (if applicable) 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(3 to 9 days after study drug dosing)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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