Ketek in CAP / AECB in Ambulatory Adult Patients

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00546676
First received: October 18, 2007
Last updated: November 13, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Community Acquired Pneumonia (CAP)
Acute Exacerbation of Chronic Bronchitis (AECB)
Drug: Telithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Evaluate speed of symptom resolution,define the safety of telithromycin,& assess health economic parameters

Enrollment: 174
Study Start Date: May 2004
Study Completion Date: December 2004
  Eligibility

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546676

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Margaret Mississian Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00546676     History of Changes
Other Study ID Numbers: HMR3647A_4018
Study First Received: October 18, 2007
Last Updated: November 13, 2007
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Pneumonia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014