Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
NCT ID: NCT02015637
Last Updated: 2018-06-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
460 participants
INTERVENTIONAL
2014-01-23
2014-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Delafloxacin
900mg orally (2 x 450 mg tablets) administered once
Delafloxacin
single dose
ceftriaxone
Ceftriaxone 250 mg intramuscular injection administered once
Ceftriaxone
single dose
Interventions
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Delafloxacin
single dose
Ceftriaxone
single dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Years
ALL
No
Sponsors
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Melinta Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sue Cammarata, MD
Role: STUDY_DIRECTOR
Melinta Therapeutics, Inc.
Locations
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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
Countries
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References
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Hook EW 3rd, Golden MR, Taylor SN, Henry E, Tseng C, Workowski KA, Swerdlow J, Nenninger A, Cammarata S. Efficacy and Safety of Single-Dose Oral Delafloxacin Compared With Intramuscular Ceftriaxone for Uncomplicated Gonorrhea Treatment: An Open-Label, Noninferiority, Phase 3, Multicenter, Randomized Study. Sex Transm Dis. 2019 May;46(5):279-286. doi: 10.1097/OLQ.0000000000000971.
Other Identifiers
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ML-3341-304
Identifier Type: -
Identifier Source: org_study_id
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