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

• 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: Pfizer
• 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: January 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 ]

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

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

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