CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 enrolled
Drug / intervention
delafloxacin +2 moredrug
Likely dose
delafloxacin 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00719810
NCT00719810Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of RX 3341 Compared With Tigecycline for the Treatment of Complicated Skin and Skin Structure Infections

Melinta Therapeutics, Inc.·interventional·Posted Jul 22, 2008·Updated Jul 14, 2014

In Brief

A Phase 2 clinical trial evaluating delafloxacin and tigecycline for Skin Structure Infections and 2 related conditions. Completed, enrolled 150 participants across 14 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Structure Infections, Bacterial Skin Diseases, Staphylococcal Skin Infections
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2008
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.9 years ago

Interventions

delafloxacindrug

300 mg intravenous every 12 hours

delafloxacindrug

450 mg intravenous every 12 hours

tigecyclinedrug

100 mg then 50 mg intravenous tigecycline every 12 hours