Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

Stopped early · Phase 3

Conditions studied: Gonorrhea

In brief

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.

Key facts

Study ID: NCT02015637
Run by: Melinta Therapeutics, Inc.
People needed: 460
Starts: 2014-01-23
Expected to finish: 2014-12-10
Last updated by the study team: 2018-06-20

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is a male or female 15 years of age or older.
Subject must have had 1 or more of the following occur:
gonorrhea with the nucleic acid amplification test (NAAT) or culture within the previous 14 days
unprotected genital contact within 14 days with a person confirmed to be infected with gonorrhea,
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.

You may not qualify if…

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.

Where it is running

Melinta 304 Study — Birmingham, Alabama, United States
Melinta 304 Study Site — Chula Vista, California, United States
Melinta 304 Study Site — La Mesa, California, United States
Melinta 304 Study Site — Los Angeles, California, United States
Melinta 304 Study Site — San Francisco, California, United States
Melinta 304 Study — Atlanta, Georgia, United States
Melinta 304 Study — Decatur, Georgia, United States
Melinta 304 Study Site — Indianapolis, Indiana, United States
Melinta 304 Study Site — New Orleans, Louisiana, United States
Melinta 304 Study Site — Omaha, Nebraska, United States
Melinta 304 Study Site — Las Vegas, Nevada, United States
Melinta 304 Study Site — Brooklyn, New York, United States
Melinta 304 Study — Brooklyn, New York, United States
Melinta 304 Study Site — New York, New York, United States
Melinta 304 Study Site — The Bronx, New York, United States
Melinta 304 Study Site — Durham, North Carolina, United States
Melinta 304 Study Site — Greensboro, North Carolina, United States
Melinta 304 Study Site — Cleveland, Ohio, United States
Melinta 304 Study Site — Columbus, Ohio, United States
Melinta 304 Study Site — Portland, Oregon, United States
Melinta 304 Study — Erie, Pennsylvania, United States
Melinta 304 Study Site — Philadelphia, Pennsylvania, United States
Melinta 304 Study Site — Pittsburgh, Pennsylvania, United States
Melinta 304 Study Site — Houston, Texas, United States
Melinta 304 Study Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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