Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

May 23, 2018 updated by: Melinta Therapeutics, Inc.

A Comparative Evaluation of the Single-dose Efficacy of Oral Delafloxacin Versus the Single-dose Efficacy of an Intramuscular Injection of Ceftriaxone in Subjects With Uncomplicated Urogenital Gonorrhea

The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Melinta 304 Study
    • California
      • Chula Vista, California, United States, 90911
        • Melinta 304 Study Site
      • La Mesa, California, United States, 91942
        • Melinta 304 Study Site
      • Los Angeles, California, United States, 90069
        • Melinta 304 Study Site
      • San Francisco, California, United States, 94103
        • Melinta 304 Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Melinta 304 Study
      • Decatur, Georgia, United States, 30033
        • Melinta 304 Study
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Melinta 304 Study Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Melinta 304 Study Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Melinta 304 Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Melinta 304 Study Site
    • New York
      • Bronx, New York, United States, 100461
        • Melinta 304 Study Site
      • Brooklyn, New York, United States, 11203
        • Melinta 304 Study Site
      • Brooklyn, New York, United States, 11203
        • Melinta 304 Study
      • New York, New York, United States, 10018
        • Melinta 304 Study Site
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Melinta 304 Study Site
      • Greensboro, North Carolina, United States, 27405
        • Melinta 304 Study Site
    • Ohio
      • Cleveland, Ohio, United States, 44108
        • Melinta 304 Study Site
      • Columbus, Ohio, United States, 43231
        • Melinta 304 Study Site
    • Oregon
      • Portland, Oregon, United States, 97204
        • Melinta 304 Study Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Melinta 304 Study
      • Philadelphia, Pennsylvania, United States, 191007
        • Melinta 304 Study Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Melinta 304 Study Site
    • Texas
      • Houston, Texas, United States, 77011
        • Melinta 304 Study Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Melinta 304 Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is a male or female 15 years of age or older.

  • Subject must have had 1 or more of the following occur:

    1. gonorrhea with the nucleic acid amplification test (NAAT) or culture within the previous 14 days
    2. unprotected genital contact within 14 days with a person confirmed to be infected with gonorrhea,
    3. gram-negative present in urogenital gram strain or male subject must present with purulent urethritis or a female subject with must present with mucopurulent cervical discharge
  • Subject agrees to avoid unprotected sexual contact in order to minimize the risk of gonorrhea reinfection
  • Subject must be in good health (ie, based on medical history), as determined by the investigator.
  • In the opinion of the investigator, the subject must be able and willing to comply with protocol requirements. The subject must agree to provide reliable, verifiable contact information and agree to return for the Test-of-Cure Visit.
  • If a subject's age is 15 years to less than the legal age of consent,a written, voluntarily signed assent must be obtained from the subject and a written, voluntarily signed informed consent must be signed by the subject's parent or legal guardian before the initiation of any study related procedures, unless the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determines that parent/legal guardian consent is not required.

Exclusion Criteria:

  • Confirmed, or suspected, complicated or systemic gonococcal infection, such as pelvic inflammatory disease, arthritis, or endocarditis.
  • Subject has taken one of the following products within 6 hours of the Entry Visit that may interfere with the absorption of a quinolone antibiotic: magnesium/aluminum antacids; sucralfate; Videx® (didanosine) chewable/buffered tablets; other highly buffered drugs; or other products containing calcium, iron, or zinc.
  • Use of systemic or intravaginal antibiotics that are potentially effective against gonorrhea 4 weeks prior to study drug administration.
  • Subjects with a current or prior history of seizures, and subjects being treated with drugs that are known to have a sizable potential of or reduce the threshold for inducing seizures (eg, bupropion, theophylline, and tricyclic and tetracyclic antidepressants).
  • Current use of systemic corticosteroid or immunosuppressive drugs.
  • Known significant immunosuppression (eg, cluster of differentiation (CD4) cell count <200/mm3 or absolute neutrophil count <500/mL).
  • Cytotoxic chemotherapy or radiation therapy during the previous 3 months.
  • Subject is co-infected with an additional sexually transmitted disease (STD) for which treatment cannot be safely deferred until after the Test-of-Cure Visit unless the treatment is not potentially effective against gonorrhea.
  • Subject has used an investigational drug or product within 30 days before study drug dosing.
  • Medical history of Type 1 hypersensitivity to antibiotics of the quinolone or cephalosporin classes.
  • Hysterectomized subjects without a cervix are ineligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delafloxacin
900mg orally (2 x 450 mg tablets) administered once
Drug: Delafloxacin
single dose
Active Comparator: ceftriaxone
Ceftriaxone 250 mg intramuscular injection administered once
Drug: Ceftriaxone
single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population
Time Frame: Day 7 (± 3 days)
Cure for the primary outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.
Day 7 (± 3 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population
Time Frame: Day 7 (± 3 days)
Cure for the seconday outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.
Day 7 (± 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melinta Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 10, 2014

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 19, 2013

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML-3341-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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