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Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

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ClinicalTrials.gov Identifier: NCT02015637
Recruitment Status : Terminated
First Posted : December 19, 2013
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Gonorrhea Drug: Delafloxacin Drug: Ceftriaxone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 23, 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 10, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gonorrhea
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Microbiological Outcome of Urogenital Gonorrhea at TOC [ 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.


Secondary Outcome Measures :
  1. Microbiological Outcome of Urogenital Gonorrhea at TOC [ Time Frame: Day 7 (± 3 days) ]
    Cure for the secondary outcome measure for the urogenital site was defined as a negative culture obtained at TOC from the urogenital site that tested positive at study entry.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015637


  Show 25 Study Locations
Sponsors and Collaborators
Melinta Therapeutics, Inc.
Investigators
Study Director: Sue Cammarata, MD Melinta Therapeutics, Inc.

Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02015637     History of Changes
Other Study ID Numbers: ML-3341-304
First Posted: December 19, 2013    Key Record Dates
Results First Posted: April 26, 2018
Last Update Posted: April 26, 2018
Last Verified: March 2018

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
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action