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)

This study has been terminated.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00237445
First received: October 10, 2005
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Pneumonia
Drug: telithromycin
Drug: azithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • To compare the effect of telithromycin versus azithromycin on clinical efficacy in CAP adult outpatients at the end of therapy [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: November 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237445

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Phyllis Diener Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00237445     History of Changes
Other Study ID Numbers: HMR3647A_4027
Study First Received: October 10, 2005
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014