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Trial record 1 of 1 for:    NCT00939185
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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
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date July 13, 2009
First Posted Date July 14, 2009
Results First Submitted Date December 17, 2009
Results First Posted Date March 18, 2010
Last Update Posted Date March 30, 2010
Study Start Date April 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2010)
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.
Original Primary Outcome Measures
 (submitted: July 13, 2009)
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 ]
Change History Complete list of historical versions of study NCT00939185 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 25, 2010)
  • 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.
Original Secondary Outcome Measures
 (submitted: July 13, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
Official Title Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
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.
Detailed Description Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Respiratory Tract Infections
Intervention 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
Study Groups/Cohorts Azithromycin group
Intervention: Drug: Azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 13, 2009)
400
Original Actual Enrollment Same as current
Actual Study Completion Date January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 14 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00939185
Other Study ID Numbers A0661182
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2010