Back to resultsKetek in CAP / AECB in Ambulatory Adult Patients
Primary Purpose
Community Acquired Pneumonia (CAP), Acute Exacerbation of Chronic Bronchitis (AECB)
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Telithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Community Acquired Pneumonia (CAP)
Eligibility 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.
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00546676
Brief Title
Ketek in CAP / AECB in Ambulatory Adult Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia (CAP), Acute Exacerbation of Chronic Bronchitis (AECB)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Telithromycin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluate speed of symptom resolution,define the safety of telithromycin,& assess health economic parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Mississian
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Ketek in CAP / AECB in Ambulatory Adult Patients
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