Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
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
1 other identifier
interventional
460
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2014
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2013
CompletedFirst Posted
Study publicly available on registry
December 19, 2013
CompletedStudy Start
First participant enrolled
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2014
CompletedResults Posted
Study results publicly available
April 26, 2018
CompletedJune 20, 2018
May 1, 2018
9 months
December 13, 2013
March 26, 2018
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population
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 Outcomes (1)
Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population
Day 7 (± 3 days)
Study Arms (2)
Delafloxacin
EXPERIMENTAL900mg orally (2 x 450 mg tablets) administered once
ceftriaxone
ACTIVE COMPARATORCeftriaxone 250 mg intramuscular injection administered once
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Melinta 304 Study
Birmingham, Alabama, 35294, United States
Melinta 304 Study Site
Chula Vista, California, 90911, United States
Melinta 304 Study Site
La Mesa, California, 91942, United States
Melinta 304 Study Site
Los Angeles, California, 90069, United States
Melinta 304 Study Site
San Francisco, California, 94103, United States
Melinta 304 Study
Atlanta, Georgia, 30308, United States
Melinta 304 Study
Decatur, Georgia, 30033, United States
Melinta 304 Study Site
Indianapolis, Indiana, 46202, United States
Melinta 304 Study Site
New Orleans, Louisiana, 70112, United States
Melinta 304 Study Site
Omaha, Nebraska, 68114, United States
Melinta 304 Study Site
Las Vegas, Nevada, 89109, United States
Melinta 304 Study Site
Brooklyn, New York, 11203, United States
Melinta 304 Study
Brooklyn, New York, 11203, United States
Melinta 304 Study Site
New York, New York, 10018, United States
Melinta 304 Study Site
The Bronx, New York, 100461, United States
Melinta 304 Study Site
Durham, North Carolina, 27701, United States
Melinta 304 Study Site
Greensboro, North Carolina, 27405, United States
Melinta 304 Study Site
Cleveland, Ohio, 44108, United States
Melinta 304 Study Site
Columbus, Ohio, 43231, United States
Melinta 304 Study Site
Portland, Oregon, 97204, United States
Melinta 304 Study
Erie, Pennsylvania, 16507, United States
Melinta 304 Study Site
Philadelphia, Pennsylvania, 191007, United States
Melinta 304 Study Site
Pittsburgh, Pennsylvania, 15213, United States
Melinta 304 Study Site
Houston, Texas, 77011, United States
Melinta 304 Study Site
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 30985632DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan K. Cammarata, M.D. (Chief Medical Officer)
- Organization
- Melinta Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Sue Cammarata, MD
Melinta Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2013
First Posted
December 19, 2013
Study Start
January 23, 2014
Primary Completion
November 1, 2014
Study Completion
December 10, 2014
Last Updated
June 20, 2018
Results First Posted
April 26, 2018
Record last verified: 2018-05