Clinical Trials

Date: 2014-05-05

Type of information: Initiation of patient enrollment

phase: 3

Announcement: initiation of patient enrollment

Company: Melinta Therapeutics (USA - CT)

Product: delafloxacin

Action mechanism:

• antibiotic. Delafloxacin is an investigational anionic fluoroquinolone antibiotic currently in Phase 3 clinical development for hospital-treated skin infections, known as acute bacterial skin and skin structure infections (ABSSSI).
•  In clinical trials, delafloxacin is being tested in both IV and oral formulations.
• Delafloxacin was designated a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of ABSSSI.

Disease: acute bacterial skin and skin structure infections (ABSSSI)

Therapeutic area: Infectious diseases

Country: Croatia, Israel, Latvia, Russian Federation, Spain, Ukraine, USA

Trial details: The ML-3341-303 study is a double-blind and double-dummy design in which approximately 660 patients with ABSSSI are expected to be enrolled. The purpose of this study is to evaluate the effects of delafloxacin versus vancomycin plus aztreonam in the treatment of patients with complicated bacterial and soft tissue infections. Patients will be randomized to receive either delafloxacin or vancomycin plus aztreonam. Patients in the delafloxacin arm will receive I.V. delafloxacin twice daily for three days, after which they will switch to oral delafloxacin twice daily. Patients in the control arm will receive I.V. vancomycin plus aztreonam every 12 hours. All patients will receive a minimum of 5 days of dosing, with a maximum of 14 days of treatment at the investigators’ discretion. (NCT01811732)

Latest news:

• • On May 5, 2014, Melinta Therapeutics announced that patient enrollment has commenced in a Phase 3 trial of oral and intravenous delafloxacin in adults with acute bacterial skin and skin structure infections (ABSSSI). This study compares the efficacy and safety of both formulations of delafloxacin to a control regimen of I.V. vancomycin plus aztreonam.
• Results from this Phase 3 study and those from a second, ongoing Phase 3 study of I.V. delafloxacin  are expected to support the filing of regulatory applications with the FDA and foreign regulators.

Is general: Yes