Ketek in CAP / AECB in Ambulatory Adult Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telithromycin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margaret Mississian

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HMR3647A_4018

Identifier Type: -

Identifier Source: org_study_id