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A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

NCT02269644 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-01-22

No results posted yet for this study

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.

Conditions

  • Community Acquired Pneumonia

Interventions

DRUG

Dalbavancin

dalbavancin 1500 mg IV over 30 minutes on Day 1

DRUG

Linezolid

linezolid 600 mg every 12 hours for a minimum of 10 days and a maximum of 14 days

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

DRUG

Azithromycin

Dalbavancin and linezolid randomized subjects on Day 1, 1st dose receive 500 mg of IV azithromycin

Sponsors & Collaborators

  • Durata Therapeutics Inc., an affiliate of Allergan plc

    lead INDUSTRY

Principal Investigators

  • Urania Rappo, MD · Durata Therapeutics Inc., an affiliate of Allergan plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02269644 on ClinicalTrials.gov