Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

NCT02015637 ↗

Phase 3 Terminated 460 enrolled Melinta Therapeutics, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2014-01-23
Primary completion: 2014-11
Completion: 2014-12-10

Outcome

Missed primary endpoint

paper Because the lower bound of the confidence interval exceeded the prespecified -10% NI margin, delafloxacin did not demonstrate NI to ceftriaxone. PMID 30985632 ↗

paper urogenital cure rates for delafloxacin were 85.1% (194/228) versus 91.0% (91/100) for ceftriaxone (95% confidence interval, -13.18% to 1.36%). PMID 30985632 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ceftriaxone	Other / unclassified	250 mg	Intramuscular
Subject	Delafloxacin	Small molecule	900 mg	Oral