Ketek in CAP / AECB in Ambulatory Adult Patients

Community Acquired Pneumonia (CAP) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546676
• Other study ID #: HMR3647A_4018
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2007
• Last updated: November 13, 2007
• Start date: May 2004
• Est. completion date: December 2004

Study information

• Verified date: November 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Bronchitis (AECB)
• Bronchitis
• Bronchitis, Chronic
• Community Acquired Pneumonia (CAP)
• Pneumonia

Intervention

Drug:
• Telithromycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate speed of symptom resolution,define the safety of telithromycin,& assess health economic parameters