Respiratory Tract Infections Clinical Trial
Official title:
An Open, Multicenter, Non-comparative, Phase IV Trial of Efficacy and Safety of Ketek(Telithromycin) 800mg
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
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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