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.
Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.
Study Type
OBSERVATIONAL
Enrollment
400
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.
Number of Patients With Adverse Events (AEs)
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.
Time frame: 3 to 7 days after receiving treatment
Number of Subjects Who Withdrew From the Study
Time frame: 3 to 7 days after receiving treatment
Compliance
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 frame: 3 to 7 days after receiving treatment
Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital
Time of exam completion minus the start time of the examination.
Time frame: Day 1
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