Back to resultsEfficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
Primary Purpose
Sinusitis
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
placebo
azithromycin
Sponsored by
About this trial
This is an interventional prevention trial for Sinusitis focused on measuring sinusitis, azithromycin
Eligibility 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.
Sites / Locations
- Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
azithromycin
placebo
Arm Description
azithrimycin 3 days/week
placebo 3 days/week
Outcomes
Primary Outcome Measures
frequence of acute sinusitis during 12 mouths of study period
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00944515
Brief Title
Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
Official Title
Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children : A Prospective, Randomized, Double-blind, Placebo Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing recurrent acute sinusitis in children.
Detailed Description
A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in preventing recurrent acute sinusitis in children
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
sinusitis, azithromycin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
azithromycin
Arm Type
Active Comparator
Arm Description
azithrimycin 3 days/week
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo 3 days/week
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet or syrup 3 days/week
Intervention Type
Drug
Intervention Name(s)
azithromycin
Other Intervention Name(s)
treatment
Intervention Description
azithromycin 3 days/week
Primary Outcome Measure Information:
Title
frequence of acute sinusitis during 12 mouths of study period
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orathai - Piboonpocanun, MD
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
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