A P3 Comparator Trial in Community Acquired Bacterial Pneumonia
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|ClinicalTrials.gov Identifier: NCT02269644|
Recruitment Status : Withdrawn
First Posted : October 21, 2014
Last Update Posted : January 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Community Acquired Pneumonia||Drug: Dalbavancin Drug: Linezolid Drug: Linezolid Placebo Drug: Azithromycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Double-blinded, Randomized, Comparator Trial of the Safety and Efficacy of a Single Dose of Dalbavancin to Twice Daily Linezolid for the Treatment of Community Acquired Bacterial Pneumonia|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
Dalbavancin randomized subjects will receive one dose of dalbavancin 1500 mg IV over 30 minutes on Day 1 plus azithromycin 500 mg IV on Day 1. Dalbavancin dose will be adjusted for subjects with significant renal insufficiency who are not receiving regular hemodialysis. All patients in the dalbavancin group will receive placebo linezolid infusions or tablets to maintain the blinding. Dalbavancin dose will be adjusted for subjects with significant renal insufficiency who are not receiving regular hemodialysis
dalbavancin 1500 mg IV over 30 minutes on Day 1
Other Name: Dalvance
Active Comparator: Linezolid
Linezolid randomized subjects will receive linezolid 600 mg every 12 hours for a minimum of 10 days, and a maximum of 14 days. All patients will receive at least one IV dose of linezolid initially plus azithromycin 500 mg IV only on Day 1. Subjects then may then be switched to oral linezolid at the discretion of the investigator, if clinical improvement in the signs and symptoms of pneumonia is observed, to complete the 10-14 day course of therapy,. No dose adjustment is required for renal insufficiency.
linezolid 600 mg every 12 hours for a minimum of 10 days and a maximum of 14 days
Other Name: Zyvox
Linezold Placebo IV and Oral Capsules
Dalbavancin randomized subjects after the 1st dose on Day 1 will receive placebo linezolid every 12 hours for a minimum of 10 days and a maximum of 14 days. Dalbavancin randomized subjects may be switched to oral linezolid placebo therapy to complete the 10-14 day course of therapy.
Drug: Linezolid Placebo
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
Dalbavancin and linezolid randomized subjects on Day 1, 1st dose will also receive 500 mg of IV azithromycin
Dalbavancin and linezolid randomized subjects on Day 1, 1st dose receive 500 mg of IV azithromycin
- Treatment Response of CABP Symptoms [ Time Frame: Change from Baseline to 72-120 hours after randomization ]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.
- Efficacy of dalbavancin to the comparator regimen [ Time Frame: Change from baseline to 72-120 hours after randomization, Day 14 and Day 28 ]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
- Safety Analysis [ Time Frame: Safety will be assessed at all time-points through Day 28 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269644
|United States, Montana|
|Mercury Street Medical Group|
|Butte, Montana, United States, 59701|
|Study Director:||Urania Rappo, MD||Durata Therapeutics Inc., an affiliate of Allergan plc|