Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections

NCT04042077 ↗

Phase 3 Terminated 268 enrolled Menarini Group

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site infection following a cardiothoracic/related leg or abdominal surgery.

Timeline

Start: 2019-09-25
Primary completion: 2020-10-07
Completion: 2020-10-28

Publications

Belev N, Tein A, Mangialardi G, Nuti A, Marino Merlo G, Scartoni S, Bertolotti M, Lerro M, Margaritora S. A Randomized, Observer-Blinded, Active-Controlled, Phase IIIb Study to Compare IV/Oral Delafloxacin Fixed-Dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections: The DRESS Study. Open Forum Infect Dis. 2025 Aug 29;12(9):ofaf476. doi: 10.1093/ofid/ofaf476. eCollection 2025 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delafloxacin	Small molecule	450 mg	Intravenous
Comparator	Linezolid	Other / unclassified	600 mg	Intravenous
Comparator	Piperacillin	Small molecule	4 g	Intravenous
Comparator	Tazobactam	Small molecule	0.5 g	Intravenous
Comparator	Tigecycline	Small molecule	50 mg	Intravenous
Comparator	Vancomycin	Other / unclassified	15 mg/kg	Intravenous

Indications

No indication recorded.