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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2009

Last Updated Date

March 25, 2010

Start Date ^ICMJE

April 2007

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00939185 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Respiratory Tract Infections

Intervention ^ICMJE

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 Group/Cohort (s)

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 ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

1 Year to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00939185

Other Study ID Numbers ^ICMJE

A0661182

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2010

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

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