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NCT00944515 Clinical Trial

Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

Sinusitis Clinical Trial

Official title:
Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children : A Prospective, Randomized, Double-blind, Placebo Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00944515
Other study ID # 394/2551(EC4)
Secondary ID
Status Completed
Phase N/A
First received July 22, 2009
Last updated March 15, 2016
Start date August 2009
Est. completion date December 2015

Study information
Verified date March 2016
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing recurrent acute sinusitis in children.

Description:

A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in preventing recurrent acute sinusitis in children

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 15 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• placebo
placebo tablet or syrup 3 days/week
• azithromycin
azithromycin 3 days/week

Locations
Country Name City State
Thailand Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary frequence of acute sinusitis during 12 mouths of study period 12 months Yes
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