Study Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Telithromycin Once Daily for 7 Days, or Azithromycin Once Daily for 5 Days (COBRA II)

A Multinational, Multicenter, Randomized, Double-blind, Study in Areas of High Pneumococcal Resistance Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Ketek® Telithromycin Once Daily for 7 Days, or Zithromax® Azithromycin Once Daily for 5 Days

A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5 days

Study Overview

• Status: Terminated
• Conditions: Pneumonia
• Intervention / Treatment: Drug: azithromycin; Drug: telithromycin

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Male or female outpatients aged 20 or greater.

• Subjects with a positive Binax NOW S. pneumoniae Urinary Antigen Test and/or positive gram stain for diplococci.
• Subjects with ≤ 7 days of signs and symptoms of CAP.
• Subjects with chest x-ray findings that support a diagnosis of acute pneumonia with presence of a new infiltrate. For subjects with history of chronic obstructive pulmonary disease (COPD), a comparison to previous chest x-ray report is required to confirm the finding of new infiltrates.

Subjects with diagnosis of acute mild to moderate CAP based on at least one of the following:

• fever (oral >37.5°C/99.5°F or axillary >37.4°C/99.4°F or rectal >38.5°C/101.5°F) or
• elevated total peripheral white blood cell count >10,000/mm3 or >15% immature neutrophils (bands), regardless of total peripheral white count and

• new and sudden onset (equal or less than 48 hours) of at least two of the following signs or symptoms:

  • cough
  • dyspnea or tachypnea (particularly if progressive in nature)
  • pleuritic chest pain
  • purulent sputum production or change in sputum character
  • auscultatory findings (such as rales and/or evidence of pulmonary consolidation)

Exclusion Criteria:

• Subjects presenting with any of the following will not be included in the study.

  • Subjects with CAP requiring hospitalization.
  • Subjects with signs and symptoms of severe CAP lasting greater than 7 days.
  • Subjects requiring parenteral antibiotic treatment.
  • Subjects discharged from hospital within the 10 days before study entry.
  • Subjects with visible/gross aspiration pneumonia.
  • Subjects with any concomitant pulmonary disease, condition or complication that could confound the interpretation or evaluation of drug efficacy or safety, including:
• severe bronchiectasis, cystic fibrosis or suspected active pulmonary tuberculosis
• suspected acute pulmonary embolism
• emphysema, lung abscess, extra pulmonary extension (e.g., meningitis, septic arthritis, endocarditis)

• known bronchial obstruction or a history of postobstructive pneumonia.

  • Subjects with neoplastic lung disease (lung cancer) or another malignancy metastatic to the lungs, and/or requiring chemotherapeutic interventions for this or other neoplasms.
  • Subjects with infection requiring administration of other systemic antimicrobial agents.
  • Subjects with progressively fatal disease; life expectancy ≤3 months.
  • Subjects with myasthenia gravis.
  • Subjects with any concomitant condition, including severe and/or uncontrolled cardiovascular, neurologic, endocrine, or other severe and/or uncontrolled major systemic disease that make implementation of the protocol or interpretation of the study results difficult.
  • Immunocompromised subjects, such as:
• known HIV subjects with CD4+ T-lymphocyte count dated less than 3 months <200/mm3 and /or HIV subjects treated with isoniazide or clarithromycin as prophylaxis
• neutropenia (<1500 neutrophils/mm3) not attributable to the acute infectious disease
• metastatic or hematological malignancy
• splenectomy or known hyposplenia or asplenia

• chronic corticosteroid therapy.

  • Subjects with a history of congenital or a family history of long QT syndrome (if not excluded by previous ECG) and subjects with known acquired QT interval prolongation
  • Known severe impaired renal function as shown by creatinine clearance < 30 ml/min either measured or estimated with Cockroft formula.
  • Subjects who have received more than 24 hours of effective treatment with other antibiotics, within the 7 days prior to enrollment in the study.
  • Subjects with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to telithromycin or any macrolide antibiotic.
  • Subjects who will require on-study treatment with medications known to have potential drug interactions, including ergot alkaloids derivatives, terfenadine, astemizole, cisapride, pimozide, simvastatin, atorvastatin and lovastatin (see Section 6.2).
  • Subjects who have received any investigational drug within 1 month prior to study entry or such treatment is planned for during the study period.
  • Subjects who are pregnant or breast-feeding.
  • Subjects with recent drug or alcohol abuse.Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  • Subject is the investigator or any subinvestigator, research assistance, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
  • Subjects already enrolled in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate clinical cure rates of telithromycin over azithromycin for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high pneumococcal bacterial resistance areas, at the test of cure visit (Days 17-21).

Secondary Outcome Measures

Outcome Measure
To compare the effect of telithromycin versus azithromycin on clinical efficacy in CAP adult outpatients at the end of therapy

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: October 10, 2005
• First Submitted That Met QC Criteria: October 10, 2005
• First Posted (Estimate): October 12, 2005

Study Record Updates

• Last Update Posted (Estimate): January 11, 2011
• Last Update Submitted That Met QC Criteria: January 10, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin; Telithromycin
• Other Study ID Numbers: HMR3647A_4027