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

Sponsored by:	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 IV

Study Type:	Observational
Study Design:	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

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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 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.

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

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 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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661182
Study First Received:	July 13, 2009
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00939185 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Pfizer:

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

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Therapeutic Uses
Azithromycin
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009