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Ketek in CAP / AECB in Ambulatory Adult Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546676
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : November 14, 2007
Information provided by:

Tracking Information
First Submitted Date  ICMJE October 18, 2007
First Posted Date  ICMJE October 19, 2007
Last Update Posted Date November 14, 2007
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2007)
Evaluation of the clinical effectiveness of telithromycin treatment as determined by the clinical cure rates based on the resolution of infection-related signs and symptoms for CAP and AECB.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00546676 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2007)
Evaluate speed of symptom resolution,define the safety of telithromycin,& assess health economic parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Ketek in CAP / AECB in Ambulatory Adult Patients
Official Title  ICMJE A Canadian Multicenter, Prospective, Open Label, Non-Comparative Study of the Effectiveness and Safety of Oral Telithromycin, 800mg Once Daily in the Treatment of Either Community Acquired Pneumonia or Acute Exacerbation of Chronic Bronchitis in Ambulator
Brief Summary To determine the clinical effectiveness of telithromycin in the treatment of either CAP or AECB in a large population of ambulatory adult patients in a community-based setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Community Acquired Pneumonia (CAP)
  • Acute Exacerbation of Chronic Bronchitis (AECB)
Intervention  ICMJE Drug: Telithromycin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2007)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Male or female subjects greater than or equal to 18 years who fulfill the clinical diagnostic criteria for outpatient treatment of one of the two following community acquired respiratory tract infections (CARTIs):

  • CAP: a new pulmonary infiltrate confirmed by chest X-ray and at least 3 of the following signs or symptoms of infection: fever greater than or equal to 38C, cough, chest pain, sputum production, rales, dyspnea, malaise and/or headache; OR
  • ECB: documented medical history of chronic bronchitis in subjects over the age of 40 and presenting an FEV1 <80% of the predicted value in the last 36 months and at least 2 of the following clinical symptoms: increased sputum purulence, increased dyspnea and/or increased sputum production.

Exclusion Criteria:

  • Subjects with a confirmed cardiogenic syncope, ventricular tachyarrythmia or Torsades de Pointes while taking a medicinal product with QT- prolonging potential, such as a macrolide or quinolone antibiotic, or other non-antibiotic suspected of prolonging the QT interval;
  • Pregnancy or lactation;
  • Hypersensitivity to macrolides;
  • Concomitant treatment with terfenadine, ergot alkaloid derivatives, astemizole or pimozide;
  • Myasthenia gravis;
  • Antibiotic treatment in the 30 days prior to study entry;
  • Treatment with any investigational product in the 30 days prior to study entry and/or a previous participation in this study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00546676
Other Study ID Numbers  ICMJE HMR3647A_4018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Margaret Mississian Sanofi
PRS Account Sanofi
Verification Date November 2007

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