Trial record 1 of 1 for:
NCT00939185
Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections (COMPAS)
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ClinicalTrials.gov Identifier: NCT00939185 |
Recruitment Status :
Completed
First Posted : July 14, 2009
Results First Posted : March 18, 2010
Last Update Posted : March 30, 2010
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Sponsor:
Pfizer
Information provided by:
Pfizer
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Tracking Information | ||||
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First Submitted Date | July 13, 2009 | |||
First Posted Date | July 14, 2009 | |||
Results First Submitted Date | December 17, 2009 | |||
Results First Posted Date | March 18, 2010 | |||
Last Update Posted Date | March 30, 2010 | |||
Study Start Date | April 2007 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Number of Patients With Adverse Events (AEs) [ Time Frame: 3 to 7 days after receiving treatment ] All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.
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Original 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 ] | |||
Change History | Complete list of historical versions of study NCT00939185 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections | |||
Official Title | 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 | Observational | |||
Study Design | 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 | Respiratory Tract Infections | |||
Intervention | 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
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Study Groups/Cohorts | Azithromycin group
Intervention: Drug: Azithromycin
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
400 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | January 2009 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 1 Year to 14 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00939185 | |||
Other Study ID Numbers | A0661182 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | March 2010 |