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Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

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ClinicalTrials.gov Identifier: NCT00944515
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Orathai Piboonpocanun, Mahidol University

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

Condition or disease Intervention/treatment Phase
Sinusitis Drug: placebo Drug: azithromycin Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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.
Study Start Date : August 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Arm Intervention/treatment
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



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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944515


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

Responsible Party: Orathai Piboonpocanun, Department of Pediatrics, Faculty of medicine, Siriraj hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00944515     History of Changes
Other Study ID Numbers: 394/2551(EC4)
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Orathai Piboonpocanun, Mahidol University:
sinusitis
azithromycin

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases