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

Respiratory Tract Infections Clinical Trial

— COMPAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939185
• Other study ID #: A0661182
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2009
• Last updated: March 25, 2010
• Start date: April 2007
• Est. completion date: January 2009

Study information

• Verified date: March 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

Description:

Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Events (AEs)	All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.	3 to 7 days after receiving treatment	Yes
Secondary	Number of Subjects Who Withdrew From the Study		3 to 7 days after receiving treatment	Yes
Secondary	Compliance	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)".	3 to 7 days after receiving treatment	No
Secondary	Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital	Time of exam completion minus the start time of the examination.	Day 1	No

External Links

•   To obtain contact information for a study center near you, click here.