Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00939185

Purpose

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.

Condition	Intervention	Phase
Respiratory Tract Infections	Drug: Azithromycin	Phase 4

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections

Resource links provided by NLM:

Drug Information available for: Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	400
Study Start Date:	April 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Azithromycin group	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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	1 Year to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939185

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00939185 History of Changes
Other Study ID Numbers:	A0661182
Study First Received:	July 13, 2009
Results First Received:	December 17, 2009
Last Updated:	March 25, 2010
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Pfizer:

Compliance and Safety Study in Children with Upper and Lower Respiratory Tract Infections

Additional relevant MeSH terms:

Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Azithromycin

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012