Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Drug: placebo; Drug: azithromycin

• Registration Number: NCT00944515
• Lead Sponsor: Mahidol University

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

Study Timeline

• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Study Start: 2009-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo 3 days/week
azithromycin	azithromycin	azithrimycin 3 days/week

Primary Outcome Measures

Name	Time	Method
frequence of acute sinusitis during 12 mouths of study period	12 months

Trial Locations

Locations (1)

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand