Ketek in CAP / AECB in Ambulatory Adult Patients

Sanofi

Status and phase: Completed; Phase 4

Conditions: Community Acquired Pneumonia (CAP); Acute Exacerbation of Chronic Bronchitis (AECB)

Treatments: Drug: Telithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546676

HMR3647A_4018

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)