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Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

This study has been completed.
Information provided by (Responsible Party):
Orathai Piboonpocanun, Mahidol University Identifier:
First received: July 22, 2009
Last updated: March 15, 2016
Last verified: March 2016
The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing recurrent acute sinusitis in children.

Condition Intervention
Drug: placebo
Drug: azithromycin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children : A Prospective, Randomized, Double-blind, Placebo Controlled Trial.

Resource links provided by NLM:

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • frequence of acute sinusitis during 12 mouths of study period [ Time Frame: 12 months ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: azithromycin
azithrimycin 3 days/week
Drug: azithromycin
azithromycin 3 days/week
Other Name: treatment
Placebo Comparator: placebo
placebo 3 days/week
Drug: placebo
placebo tablet or syrup 3 days/week

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

Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00944515

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Orathai - Piboonpocanun, MD Siriraj Hospital
  More Information

Responsible Party: Orathai Piboonpocanun, Department of Pediatrics, Faculty of medicine, Siriraj hospital, Mahidol University Identifier: NCT00944515     History of Changes
Other Study ID Numbers: 394/2551(EC4)
Study First Received: July 22, 2009
Last Updated: March 15, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mahidol University:

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases processed this record on May 23, 2017