Ketek in CAP / AECB in Ambulatory Adult Patients

NCT00546676 | Completed Phase 4

• 1 other identifier: HMR3647A_4018
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Telithromycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

telithromycin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Margaret Mississian

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 19, 2007
• Study Start: May 1, 2004
• Study Completion: December 1, 2004
• Last Updated: November 14, 2007

Record last verified: 2007-11