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

Last updated on November 9, 2019

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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Descriptive Information
Brief TitleCompliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
Official TitleCompliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
Brief SummaryThe 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 DescriptionPatients were recruited from the outpatient departments of the participating sites/hospitals/clinics.
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationZITHROMAX® 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.
ConditionRespiratory Tract Infections
InterventionDrug: 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 Groups/CohortsAzithromycin 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 StatusCompleted
Actual Enrollment
 (submitted: July 13, 2009)
400
Original Actual EnrollmentSame as current
Actual Study Completion DateJanuary 2009
Actual Primary Completion DateJanuary 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages1 Year to 14 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00939185
Other Study ID NumbersA0661182
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2010

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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