Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
COMPAS
1 other identifier
observational
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 13, 2009
CompletedFirst Posted
Study publicly available on registry
July 14, 2009
CompletedResults Posted
Study results publicly available
March 18, 2010
CompletedMarch 30, 2010
March 1, 2010
1.8 years
July 13, 2009
December 17, 2009
March 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Number of Subjects Who Withdrew From the Study
3 to 7 days after receiving treatment
Compliance
3 to 7 days after receiving treatment
Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital
Day 1
Study Arms (1)
Azithromycin group
Interventions
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.
Eligibility Criteria
ZITHROMAX® administration will be considered in children / adolescents from the first year of life up to 14 years old with the following diagnoses: Acute otitis media, Sinusitis, Pharyngitis/tonsillitis, Pneumonia, Bronchitis.
You may qualify if:
- Patients with respiratory tract infections that received azithromycin according to the approved SPC as this was a non-interventional study.
You may not qualify if:
- According to the approved Summary of Product Characteristics (SPC) for Azithromycin as this was a non interventional study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only 1 subject received tablet; therefore, no suspension versus tablet efficacy data is displayed as initially planned.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 13, 2009
First Posted
July 14, 2009
Study Start
April 1, 2007
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
March 30, 2010
Results First Posted
March 18, 2010
Record last verified: 2010-03