Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections (COMPAS)
The objective of this study was to obtain data on the safety, tolerability and compliance with Zithromax in children with bacterial infections of the upper and lower respiratory tract.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections|
- Number of Patients With Adverse Events (AEs) [ Time Frame: 3 to 7 days after receiving treatment ] [ Designated as safety issue: Yes ]All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.
- Number of Subjects Who Withdrew From the Study [ Time Frame: 3 to 7 days after receiving treatment ] [ Designated as safety issue: Yes ]
- Compliance [ Time Frame: 3 to 7 days after receiving treatment ] [ Designated as safety issue: No ]Compliance was assessed by the following questions: Question 1: "Were the pediatrician's instructions during the treatment phase followed (i.e. dose, frequency and number of days)?"; Question 2: "Was it easy to understand your pediatrician's instructions regarding treatment?"; and Question 3: "Was the administration of this drug easier than any other previously used drug?" Patients could answer either "yes", "no", or "Not applicable (NA)".
- Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Time of exam completion minus the start time of the examination.
|Study Start Date:||April 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Zithromax was dispensed according to the Summary of Product Characteristics (SPC) as either a tablet or suspension. Zithromax was administered as a total dose of 30 mg/kg which was given as single daily doses of 10 mg/kg for 3 days, or as a 5 day dose starting with 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5.
Other Name: Zithromax
Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.