An Open, Multicenter, Non-comparative, Phase IV Trial of Efficacy and Safety of Ketek(Telithromycin) 800mg

Sanofi0 sitesFebruary 2005

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Respiratory Tract Infections
Sponsor: Sanofi
Primary Endpoint: Clinical Outcome (Global Assessment by the participating physicians)
Status: Completed
Last Updated: 16 years ago

Primary Objectives:

The primary objective of the study is to evaluate clinical efficacy i.e. to show that with respect to clinical cure rate, Ketek® (telithromycin) in the treatment of community acquired respiratory tract infections: community acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in outpatients.

Secondary Objectives:

The secondary objectives are to:

Further assess the efficacy of Ketek® (telithromycin) by considering the rate at which additional antibacterials were prescribed to treat the primary infection; the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data, chest X-ray and sinus X-ray if available.
Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse Event (SAE) reporting

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

December 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•General Conditions
•Outpatients
•Fulfillment of clinical diagnostic criteria for one of the following indications:
•Mild to moderate Community Acquired Pneumonia (CAP)
•Acute bacterial Exacerbation of Chronic Bronchitis (AECB)
•Acute Sinusitis (AS)
•The Criteria to be fulfilled are:
•New onset of at least two of the following:
•Production of purulent sputum
•Auscultatory findings compatible with pneumonia, e.g. rales, evidence of pulmonary consolidation

•General Conditions
•Subjects presenting with any of the following will not be included in the study:
•Treatment required during the study with ergot alkaloid derivatives, pimozide, astemizole, terfenadine, cisapride, simvastatin, atorvastatin and lovastatin, and the oral use of the benzodiazepines midazolam, triazolam and alprazolam.
•History of congenital or family history of long QT syndrome (if not excluded by ECG) or known acquired QT interval prolongation.
•Known hypersensitivity to telithromycin or to macrolide antibiotics.
•Hospital acquired infections (hospitalization for more than 72 hours within 7 days of study entry).
•Pregnant or breast-feeding women. For the women of childbearing potential it is left to the investigators discretion to establish a lack of pregnancy, e.g. with contraceptive use, menstrual pattern, urinary pregnancy test.
•Subjects with severely impaired renal function (creatinine clearance \<30 ml/min).
•Subjects that had received anti-bacterials for more than 24 hours within 7 days prior to enrollment in the study, unless the treatment has failed.
•Subjects receiving medications, including other anti-microbials or anti-cancer drugs, that could interfere with the evaluation.

Clinical Outcome (Global Assessment by the participating physicians)

Time Frame: During the Study Conduct

Rate at which additional antibacterials were prescribed to treat the primary infection(During the study conduct)
Rate of hospitalisation due to a complication of the primary infection(During the study conduct)
Assessment of chest X-ray and sinus X-ray if available.(During the study conduct)
Adverse Event (AE) and Serious Adverse Event (SAE) reported(from the inform consent signed up to the end of the study)