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

Study Overview
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Brief Summary
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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
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Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.

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

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Azithromycin group<br> | Drug: Azithromycin<br>* 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.<br>* Other names: Zithromax;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Withdrew From the Study |  | 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). | 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. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compliance and Safety Study in Children with Upper and Lower Respiratory Tract Infections