Delafloxacin

Generic Name
Delafloxacin
Brand Names
Baxdela, Quofenix
Drug Type
Small Molecule
Chemical Formula
C18H12ClF3N4O4
CAS Number
189279-58-1
Unique Ingredient Identifier
6315412YVF
Background

Delafloxacin is a fluoroquinolone antibiotic which has been used in trials studying the treatment and basic science of Gonorrhea, Hepatic Impairment, Bacterial Skin Diseases, Skin Structure Infections, and Community Acquired Pneumonia, among others. It was approved in June 2017 under the trade name Baxdela for use in the treatment of acute bacterial skin and...

Indication

Delafloxacin is indicated for the treatment of acute bacterial skin and skin structure infections caused by the Gram-positive organisms Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Strept...

Associated Conditions
Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP)
Associated Therapies
-

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

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2024-09-25
Last Posted Date
2024-11-25
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
16
Registration Number
NCT06612255
Locations
🇬🇧

Quotient Sciences, Ruddington, Nottingham, United Kingdom

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

First Posted Date
2019-08-01
Last Posted Date
2022-02-02
Lead Sponsor
Menarini Group
Target Recruit Count
268
Registration Number
NCT04042077
Locations
🇮🇹

Hospital Agostino Gemelli, Roma, Italy

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

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-05-23
Last Posted Date
2018-08-15
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
30
Registration Number
NCT03534622
Locations
🇺🇸

Pulmonary Associates, Phoenix, Arizona, United States

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

First Posted Date
2016-02-10
Last Posted Date
2020-02-27
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
860
Registration Number
NCT02679573
Locations
🇺🇦

Melinta 306 Study Site, Zhytomyr, Ukraine

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

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-07-22
Last Posted Date
2016-12-16
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
22
Registration Number
NCT02505997
Locations
🇺🇸

PPD Development, LP, Austin, Texas, United States

Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-09-19
Last Posted Date
2015-04-30
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
40
Registration Number
NCT02245243
Locations
🇺🇸

Melinta 112 Study Site, Orlando, Florida, United States

Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2013-12-19
Last Posted Date
2018-06-20
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
460
Registration Number
NCT02015637
Locations
🇺🇸

Melinta 304 Study, Erie, Pennsylvania, United States

🇺🇸

Melinta 304 Study Site, Seattle, Washington, United States

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

First Posted Date
2013-11-15
Last Posted Date
2017-11-17
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
850
Registration Number
NCT01984684
Locations
🇨🇳

Melinta 303 Study Site, Zhonghe, Taiwan

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

First Posted Date
2013-03-15
Last Posted Date
2017-09-27
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
660
Registration Number
NCT01811732
Locations
🇺🇦

Melinta Investigational Site, Zaporizhzhia, Ukraine

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

First Posted Date
2011-01-26
Last Posted Date
2019-10-16
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
256
Registration Number
NCT01283581
Locations
🇺🇸

University of South Alabama Medical Center, Mobile, Alabama, United States

🇺🇸

Southbay Pharma Research, Buena Park, California, United States

🇺🇸

Drug Research and Analysis Corp, Montgomery, Alabama, United States

and more 22 locations
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