Clinical Trials

Date: 2016-01-06

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: Melinta Therapeutics (USA - CT)

Product: Baxdela® (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.

Disease: community-acquired bacterial pneumonia (CABP)

Therapeutic area: Infectious diseases

Country: Argentina, Bulgaria, Colombia, Georgia, Germany, Hungary, Latvia, Poland, Romania, Russian Federation, Serbia, Slovenia, South Africa, Spain, Ukraine, USA

Trial details: The primary efficacy endpoint is improvement at 96 hours after the first dose in at least two of the following symptoms: chest pain, frequency or severity of cough, amount of productive sputum, and difficulty breathing. Additional efficacy and safety measures will also be captured. (NCT02679573)

Latest news: • On January 6, 2016, Melinta Therapeutics announced the initiation of an international Phase 3 trial comparing Baxdela® (delafloxacin) to moxifloxacin for the treatment of hospitalized patients with radiographic evidence of community-acquired bacterial pneumonia (CABP). Melinta anticipates enrolling approximately 860 adult patients in a multi-national trial who will be randomized 1:1 to receive either Baxdela®  or moxifloxacin in a blinded fashion. Study participants will be assessed for clinical response 96 hours after the first dose (primary endpoint), at end of therapy, 5-to-10 days after the last dose, and at a follow-up contact 28 days after the last dose. (The study is expected to conclude in 2017.  

Is general: Yes