This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.
This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of CABP. Adult patients who meet all inclusion and none of the exclusion criteria will be randomized to one of the two treatment arms. Dosing will commence on Day 1, and all patients will receive a minimum of 10 days of therapy. Patients will be assessed on Day 1, Day 4-5, Day 7, Day 14 (End of Therapy, EOT), and Day 28 (Follow up).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
dalbavancin 1500 mg IV over 30 minutes on Day 1
linezolid 600 mg every 12 hours for a minimum of 10 days and a maximum of 14 days
Dalbavancin randomized subjects after Day 1, 1st dose will receive linezolid placebo every 12 hours for a minimum of 10 days and a maximum of 14 days
Mercury Street Medical Group
Butte, Montana, United States
Treatment Response of CABP Symptoms
Compare the efficacy of a single 1500 mg dose of intravenous dalbavancin plus azithromycin to the comparator regimen (linezolid plus azithromycin). Response will be based on resolution of symptoms; including chest pain, shortness of breath (difficulty breathing), frequency/severity of cough and amount of sputum production. Each of these symptoms will be assessed on a 4 point scale (absent, mild, moderate or severe). A patient will be defined as a clinical responder if there is at least a 1 point improvement in 2 or more of these symptoms at 72-120 hours after randomization compared to baseline.
Time frame: Change from Baseline to 72-120 hours after randomization
Efficacy of dalbavancin to the comparator regimen
Test the efficacy of dalbavancin to the comparator regimen using alternative outcome measures including:1) improvement at Day 4-5 in at least two of the following symptoms with no worsening in any of these symptoms of CABP compared to baseline: chest pain, frequency or severity of cough, amount of productive sputum, and difficulty breathing and improvement in vital signs (i.e. temperature, heart rate, respiratory rate or blood pressure); 2) clinical outcome (using primary response criteria) at Day 14; 3) Investigator Assessment of Outcome at Day 14 and Day 28, with success defined as complete resolution of symptoms and signs attributable to CABP and did not receive non-trial antibacterial drugs for treatment of CABP.4) all-cause mortality at Day 28
Time frame: Change from baseline to 72-120 hours after randomization, Day 14 and Day 28
Safety Analysis
To test the safety profile of dalbavancin 1500 mg versus comparator. Safety will be assessed by means of physical examination and vital signs, collection of adverse, events and clinical laboratory tests through out the study.
Time frame: Safety will be assessed at all time-points through Day 28
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Dalbavancin and linezolid randomized subjects on Day 1, 1st dose receive 500 mg of IV azithromycin