Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Melinta Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02015637
First received: December 13, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Gonorrhea
Drug: delafloxacin
Drug: ceftriaxone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Melinta Therapeutics, Inc.:

Primary Outcome Measures:
  • Microbiological outcome of urogenital gonorrhea [ Time Frame: Day 7 (± 3 days) ] [ Designated as safety issue: No ]
    All subjects will return for the Test-of-Cure Visit. However, culture and NAAT swabs will not be collected from anatomical sites with negative cultures and NAAT results, respectively, for N. gonorrhoeae from the Entry Visit. If results are not known, a swab will be collected at each anatomical site tested at the Entry Visit.


Secondary Outcome Measures:
  • Microbiological response at all anatomical sites [ Time Frame: Day 7 (± 3 days) ] [ Designated as safety issue: No ]
  • Resolution of signs and symptoms [ Time Frame: Day 7 (± 3 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 757
Study Start Date: January 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delafloxacin
900mg orally (2 x 450 mg tablets) administered once
Drug: delafloxacin
1
Active Comparator: ceftriaxone
Ceftriaxone 250 mg intramuscular injection administered once
Drug: ceftriaxone
2
Other Name: Rocephin

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 IRB/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, 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.
  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: NCT02015637

Contacts
Contact: Sue Cammarata, MD 203-848-3342 clinicaltrials@melinta.com

  Show 24 Study Locations
Sponsors and Collaborators
Melinta Therapeutics, Inc.
Investigators
Study Director: Sue Cammarata, MD Melinta Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02015637     History of Changes
Other Study ID Numbers: ML-3341-304
Study First Received: December 13, 2013
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Melinta Therapeutics, Inc.:
Gonorrhea
N. gonorrhoeae
bacterial infection
Anti-Infective Agents
Anti-Bacterial Agents

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
Ceftriaxone
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014