Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orathai Piboonpocanun, Mahidol University
ClinicalTrials.gov Identifier:
NCT00944515
First received: July 22, 2009
Last updated: March 15, 2016
Last verified: March 2016

July 22, 2009
March 15, 2016
August 2009
December 2015   (final data collection date for primary outcome measure)
frequence of acute sinusitis during 12 mouths of study period [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
frequence of acute sinusitis during 12 mouths of study period [ Time Frame: 12 mouths ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00944515 on ClinicalTrials.gov Archive Site
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Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
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.
A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in preventing recurrent acute sinusitis in children
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Sinusitis
  • Drug: placebo
    placebo tablet or syrup 3 days/week
  • Drug: azithromycin
    azithromycin 3 days/week
    Other Name: treatment
  • Active Comparator: azithromycin
    azithrimycin 3 days/week
    Intervention: Drug: azithromycin
  • Placebo Comparator: placebo
    placebo 3 days/week
    Intervention: Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
5 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00944515
394/2551(EC4)
Yes
No
Not Provided
Orathai Piboonpocanun, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Orathai - Piboonpocanun, MD Siriraj Hospital
Mahidol University
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP