N/A
N=400
Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
Respiratory Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT00939185 ↗Enrolled (actual)
400
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Number of Patients With Adverse Events (AEs) — 27 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Azithromycin (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) |
27 | — |
| SECONDARY Number of Subjects Who Withdrew From the Study |
— | — |
| SECONDARY Compliance |
370; 13; 6; 1; 374; 9 | — |
| SECONDARY Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital |
20 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00939185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.