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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939185
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : March 18, 2010
Last Update Posted : March 30, 2010
Information provided by:

July 13, 2009
July 14, 2009
December 17, 2009
March 18, 2010
March 30, 2010
April 2007
January 2009   (Final data collection date for primary outcome measure)
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.
The primary objective was to record any adverse events (AEs) either expected or unexpected following the use of Azithromycin [ Time Frame: 3-7 days after receiving treatment ]
Complete list of historical versions of study NCT00939185 on Archive Site
  • 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.
  • tolerability [ Time Frame: 3-7 days after receiving treatment ]
  • Compliance [ Time Frame: 3-7 days after receiving treatment ]
  • time reported for a subject being consulted and diagnosed from the moment he/she entered the hospital. [ Time Frame: 3-7 days after receiving treatment ]
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Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
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.
Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.
Time Perspective: Prospective
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Non-Probability Sample
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.
Respiratory Tract Infections
Drug: Azithromycin
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
Azithromycin group
Intervention: Drug: Azithromycin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2009
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year to 14 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
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Director, Clinical Trial Disclosure Group, Pfizer, Inc.
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Study Director: Pfizer Call Center Pfizer
March 2010