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Trials / Completed

CompletedNCT00939185

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

Status
Completed
Phase
Study type
Observational
Enrollment
400 (actual)
Sponsor
Pfizer · Industry
Sex
All
Age
1 Year – 14 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAzithromycinZithromax 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.

Timeline

Start date
2007-04-01
Primary completion
2009-01-01
Completion
2009-01-01
First posted
2009-07-14
Last updated
2010-03-30
Results posted
2010-03-18

Source: ClinicalTrials.gov record NCT00939185. Inclusion in this directory is not an endorsement.

Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections (NCT00939185) · Clinical Trials Directory