Ketek in CAP / AECB in Ambulatory Adult Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00546676

Enrollment

174

Registered

2007-10-19

Start date

2004-05-31

Completion date

2004-12-31

Last updated

2007-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGTelithromycin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Evaluate speed of symptom resolution,define the safety of telithromycin,& assess health economic parameters	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026