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

Last updated on April 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Respiratory Tract Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-14 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with respiratory tract infections that received azithromycin according to the
approved SPC as this was a non-interventional study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- According to the approved Summary of Product Characteristics (SPC) for Azithromycin as
this was a non interventional study.

NCT00939185
Pfizer
Completed
Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections

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Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
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.
Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Respiratory Tract Infections
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
Azithromycin group
Intervention: Drug: Azithromycin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
January 2009
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00939185
A0661182
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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