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

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.

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Key information

Conditions

Respiratory Tract Infections Behavior Health Behavior Infections Patient Acceptance of Health Care Patient Compliance Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin

Drug

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 names: Zithromax

Primary outcomes

Number of Patients With Adverse Events (AEs)

Time frame: 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 outcomes

Number of Subjects Who Withdrew From the Study

Time frame: 3 to 7 days after receiving treatment
Compliance

Time frame: 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

Time frame: Day 1

Time of exam completion minus the start time of the examination.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Acronym: COMPAS

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jul 14, 2009
Registry last updated: Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed