Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

March 15, 2016 updated by: Orathai Piboonpocanun, Mahidol University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: azithromycin
azithrimycin 3 days/week
Drug: azithromycin
azithromycin 3 days/week
Other Names:
  • treatment
Placebo Comparator: placebo
placebo 3 days/week
Drug: placebo
placebo tablet or syrup 3 days/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frequence of acute sinusitis during 12 mouths of study period
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Orathai - Piboonpocanun, MD, Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 394/2551(EC4)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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