Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections (COMPAS)
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|ClinicalTrials.gov Identifier: NCT00939185|
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : March 18, 2010
Last Update Posted : March 30, 2010
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Tract Infections||Drug: Azithromycin||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections|
|Study Start Date :||April 2007|
|Primary Completion Date :||January 2009|
|Study Completion Date :||January 2009|
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 Name: Zithromax
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939185
|Study Director:||Pfizer CT.gov Call Center||Pfizer|