Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections

Completed

• Conditions: Respiratory Tract Infections
• Interventions: Drug: Azithromycin

• Registration Number: NCT00939185
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Results First Submitted: 2009-12-17
• Results First Submitted QC: 2010-01-25
• Status Verified: 2010-03
• Results First Posted: 2010-03-18
• Last Update Submitted: 2010-03-25
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients with respiratory tract infections that received azithromycin according to the approved SPC as this was a non-interventional study.

Exclusion Criteria

• According to the approved Summary of Product Characteristics (SPC) for Azithromycin as this was a non interventional study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azithromycin group	Azithromycin	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events (AEs)	3 to 7 days after receiving treatment	All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Who Withdrew From the Study	3 to 7 days after receiving treatment
Compliance	3 to 7 days after receiving treatment	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	Day 1	Time of exam completion minus the start time of the examination.