TerminatedPhase 3

Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

United States460 participantsStarted 2014-01-23

Plain-language 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.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population

Timeframe: Day 7 (± 3 days)

Trial details

NCT IDNCT02015637

SponsorMelinta Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

Results submitted2018-03-26

View on ClinicalTrials.gov More Gonorrhea trials