Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
Information source: Mahidol University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis
Intervention: placebo (Drug); azithromycin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s):
Orathai - Piboonpocanun, MD, Principal Investigator, Affiliation: Siriraj Hospital Mahidol University
Overall contact:
Orathai Piboonpocanun, Phone: 662-419-8888, Ext: 5942, Email: jirapongo@yahoo.com
Summary
The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing
recurrent acute sinusitis in children.
Clinical Details
Official title: Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children : A Prospective, Randomized, Double-blind, Placebo Controlled Trial.
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: frequence of acute sinusitis during 12 mouths of study period
Detailed description:
A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in
preventing recurrent acute sinusitis in children
Eligibility
Minimum age: 5 Years.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- children between the age of 5 years and 15 years with the diagnosis of recurrent
acute sinusitis who are attending the outpatient pediatric department, pediatric
allergy clinic, and the ear, nose, throat clinic.
Exclusion Criteria:
- patients who have allergic rhinitis, chronic sinusitis, a history of allergic
reactions to azithromycin or macrolides, treatments with immunotherapy or IVIG or
gentamycin solution or pneumococcal vaccine during study period.
Locations and Contacts
Orathai Piboonpocanun, Phone: 662-419-8888, Ext: 5942, Email: jirapongo@yahoo.com
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Additional Information
Starting date: August 2009
Ending date: July 2012
Last updated: July 22, 2009
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