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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)

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ClinicalTrials.gov Identifier: NCT00237445
Recruitment Status : Terminated
First Posted : October 12, 2005
Last Update Posted : January 11, 2011
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE October 10, 2005
First Posted Date  ICMJE October 12, 2005
Last Update Posted Date January 11, 2011
Study Start Date  ICMJE November 2005
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
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).
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00237445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
To compare the effect of telithromycin versus azithromycin on clinical efficacy in CAP adult outpatients at the end of therapy
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • Drug: telithromycin
  • Drug: azithromycin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 22, 2008)
110
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00237445
Other Study ID Numbers  ICMJE HMR3647A_4027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Phyllis Diener Sanofi
PRS Account Sanofi
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP