Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02269644
Study type Interventional
Source Durata Therapeutics Inc., an affiliate of Allergan plc
Contact
Status Withdrawn
Phase Phase 3
Start date November 2015
Completion date December 2016

See also
  Status Clinical Trial Phase
Completed NCT02559310 - Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia Phase 3
Completed NCT01530763 - Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP) Phase 2/Phase 3
Completed NCT02517489 - Community-Acquired Pneumonia : Evaluation of Corticosteroids Phase 3
Completed NCT02454114 - HOME FIRST Pilot: a Study of Early Supported Discharge in Patients With Lower Respiratory Tract Infections N/A
Not yet recruiting NCT01937832 - A Phase III Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia Phase 3
Completed NCT00653172 - Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia Phase 2
Recruiting NCT02139163 - Epidemiological Study on Community Acquired Pneumonia
Completed NCT03411824 - Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine
Recruiting NCT06210282 - The Effect of Focused Lung Ultrasonography on Antibiotic Prescribing in General Practice N/A
Recruiting NCT01963442 - Short Duration Treatment of Non-severe Community Acquired Pneumonia Phase 2
Terminated NCT00887276 - Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia Phase 4
Not yet recruiting NCT00390819 - Epidemiology of Community Acquired Pneumonia in North Israel N/A
Completed NCT00079885 - Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia Phase 3
Not yet recruiting NCT04158310 - Evaluation the Clinical Value of Xiyanping Injection in the Treatment of Community-acquired Pneumonia in Children
Recruiting NCT02552342 - Corticosteroid Therapy for Severe Community-Acquired Pneumonia Phase 4
Completed NCT02922387 - Smoking Cessation Intervention in Respiratory Inpatients Phase 4
Completed NCT00467701 - Community Acquired Pneumonia in Telemark and Ostfold N/A
Completed NCT04198571 - Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries
Completed NCT02107001 - Lung Ultrasound in Pleuritic Chest Pain N/A
Completed NCT01561885 - Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways N/A