Delafloxacin

DRUG13 trials

Sponsors

Assistance Publique Hopitaux De Paris, Melinta Therapeutics, Inc., Menarini Group, IRCCS San Raffaele

Conditions

Bacterial Skin DiseasesCatheter related bloodstream infections due to Staphylococcus aureusCommunity Acquired Bacterial PneumoniaGonorrheaHealthyHepatic ImpairmentMediastinitisOsteomyelitis/Septic Arthritis

Phase 1

Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

CompletedNCT02245243

Melinta Therapeutics, Inc.Hepatic Impairment

Start: 2014-09-30End: 2015-02-28Updated: 2015-04-30

Study to Evaluate the Effect of Delafloxacin on the Pharmacokinetics of Midazolam in Healthy Subjects

CompletedNCT02505997

Melinta Therapeutics, Inc.VA Drug Interactions

Start: 2015-06-30End: 2015-07-31Updated: 2016-12-16

Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults

CompletedNCT03534622

Melinta Therapeutics, Inc.Pneumonia

Start: 2018-04-30End: 2018-07-27Updated: 2018-08-15

A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults

TerminatedNCT06612255

Melinta Therapeutics, Inc.Healthy

Start: 2024-06-03End: 2024-09-11Updated: 2025-09-26

Phase 2

Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

CompletedNCT00719810

Melinta Therapeutics, Inc.Bacterial Skin Diseases, Skin Structure Infections, Staphylococcal Skin Infections

Start: 2008-06-30End: 2008-10-31Updated: 2014-07-14

A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections

CompletedNCT01283581

Melinta Therapeutics, Inc.Skin and Subcutaneous Tissue Bacterial Infections

Start: 2011-01-31End: 2011-11-30Updated: 2019-10-16

Phase 3

Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

CompletedNCT01811732

Melinta Therapeutics, Inc.Skin and Subcutaneous Tissue Bacterial Infections

Start: 2013-04-30End: 2014-07-31Updated: 2017-09-27

Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

CompletedNCT01984684

Melinta Therapeutics, Inc.Skin and Subcutaneous Tissue Bacterial Infections, Skin Structures and Soft Tissue Infections

Start: 2014-05-31End: 2016-01-31Updated: 2017-11-17

Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

TerminatedNCT02015637

Melinta Therapeutics, Inc.Gonorrhea

Start: 2014-01-23End: 2014-12-10Updated: 2018-06-20

Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia

CompletedNCT02679573

Melinta Therapeutics, Inc.Community Acquired Bacterial Pneumonia

Start: 2016-12-14End: 2018-08-07Updated: 2020-02-27

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

TerminatedNCT04042077

Menarini GroupSurgical Site Infection

Start: 2019-09-25End: 2020-10-28Updated: 2022-02-02

Randomized open-label controlled trial evaluating a single-dose intravenous Dalbavancin versus standard antibiotic therapy during catheterrelated bloodstream infections due to Staphylococcus aureus [DALICATH]

RecruitingCTIS2024-514952-34-00

Assistance Publique Hopitaux De ParisCatheter related bloodstream infections due to Staphylococcus aureus

Start: 2023-06-23Target: 406Updated: 2025-04-23

Unknown Phase

Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections.

Not yet recruitingNCT07426471

IRCCS San RaffaeleMediastinitis, Osteomyelitis/Septic Arthritis, Prosthetic Joint Infection +1

Start: 2026-04-01End: 2027-01-31Target: 20Updated: 2026-02-23

Related Papers

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 Infectious Diseases2025-08-29

A Phase 3 Study to Compare Delafloxacin With Moxifloxacin for the Treatment of Adults With Community-Acquired Bacterial Pneumonia (DEFINE-CABP).

2019-12-0530 citations

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

Sexually Transmitted Diseases2019-02-0241 citations

Safety of Delafloxacin: Focus on Adverse Events of Special Interest

Open Forum Infectious Diseases2018-09-1031 citations

A Comparison of the Efficacy and Safety of Intravenous Followed by Oral Delafloxacin With Vancomycin Plus Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Multinational, Double-Blind, Randomized Study

Clinical Infectious Diseases2018-03-04102 citations

Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study.

2017-12-0171 citations

<i>In Vitro</i> Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections

Antimicrobial Agents and Chemotherapy2017-06-2084 citations

The Pharmacokinetics of the CYP3A Substrate Midazolam After Steady-state Dosing of Delafloxacin

Clinical Therapeutics2017-05-0931 citations

A randomized, double-blind, Phase 2 study to evaluate subjective and objective outcomes in patients with acute bacterial skin and skin structure infections treated with delafloxacin, linezolid or vancomycin.

2015-12-1757 citations