A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

NCT02269644 | Withdrawn Phase 3 DMC

• 2 other identifiers: DUR001-3052014-002683-32
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline to 72-120 hours after randomization

Secondary Outcomes (2)

• Efficacy of dalbavancin to the comparator regimen

  Change from baseline to 72-120 hours after randomization, Day 14 and Day 28

• Safety Analysis

  Safety will be assessed at all time-points through Day 28

Study Arms (4)

Dalbavancin

EXPERIMENTAL

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

Drug: Dalbavancin

Linezolid

ACTIVE COMPARATOR

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.

Drug: Linezolid

Linezold Placebo IV and Oral Capsules

OTHER

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

Azithromycin

OTHER

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

Drug: Azithromycin

Interventions

Dalbavancin DRUG

dalbavancin 1500 mg IV over 30 minutes on Day 1

Also known as: Dalvance

Dalbavancin

Linezolid DRUG

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

Also known as: Zyvox

Linezolid

Linezolid Placebo DRUG

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

Linezold Placebo IV and Oral Capsules

Azithromycin DRUG

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

Azithromycin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 85, inclusive
• Has given written, informed consent
• Has acute illness with onset within previous 7 days
• Has at least 2 of the following symptoms:
• Difficulty breathing or shortness of breath
• Cough
• Production of purulent sputum
• Pleuritic chest pain
• Has at least 2 vital sign abnormalities:
• Fever (\> 38°C or \< 35°C)
• Hypotension (systolic BP \< 90 mm Hg)
• Tachycardia (\> 100 beats /min)
• Tachypnea (\> 24 breaths /min)
• Has at least one other clinical or laboratory abnormalities:
• Hypoxemia (room air SaO2 \< 90% )

You may not qualify if:

• Contra-indication to the administration of any of the study treatments, such as hypersensitivity to any of the glycopeptide agents, beta-lactam agents, linezolid or macrolide antibiotics, or current or recent (within 2 weeks) use of MAO inhibitors or serotonergic antidepressants (within 5 weeks for fluoxetine) (see Section 5.5.1)
• Has received antibiotic therapy in the 4 days prior to screening, with the following exception: up to 25% of patients may have received a single dose of a short acting (half life \< 8 hours) antibiotic
• Has aspiration pneumonia
• Has hospital acquired or ventilator associated pneumonia, or healthcare associated pneumonia, or 2 or more days in hospital in the previous 90 days
• Has cystic fibrosis or known or suspected Pneumocystis pneumonia or known or suspected active tuberculosis
• Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant
• Has primary or metastatic lung cancer
• Has known bronchial obstruction or a history of post-obstructive pneumonia
• Requires admission to ICU at baseline
• Has empyema requiring drainage
• Infection due to an organism known prior to study entry to be resistant to either treatment regimen
• Has known or suspected infection due solely to an atypical pathogen such as Mycoplasma sp., Chlamydia sp. or Legionella sp. or positive Legionella urinary antigen at baseline
• Absolute neutrophil count \< 500 cells/mm3
• Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count \< 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count
• Patients with a recent bone marrow transplant (in post-transplant hospital stay)

Sponsors & Collaborators

• Durata Therapeutics Inc., an affiliate of Allergan plc: lead

Study Sites (1)

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

dalbavancin; Linezolid; Azithromycin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Urania Rappo, MD

  Durata Therapeutics Inc., an affiliate of Allergan plc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 21, 2014
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

US (1)