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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00939185
First received: July 13, 2009
Last updated: March 25, 2010
Last verified: March 2010

July 13, 2009
March 25, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00939185 on ClinicalTrials.gov Archive Site
  • Number of Subjects Who Withdrew From the Study [ Time Frame: 3 to 7 days after receiving treatment ] [ Designated as safety issue: Yes ]
  • Compliance [ Time Frame: 3 to 7 days after receiving treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time of exam completion minus the start time of the examination.
  • tolerability [ Time Frame: 3-7 days after receiving treatment ] [ Designated as safety issue: Yes ]
  • compliance [ Time Frame: 3-7 days after receiving treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
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.
Both
1 Year to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00939185
A0661182
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP