Sinusitis | Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
Sinusitis research study
What is the primary objective of this study?
The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing recurrent acute sinusitis in children.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:placeboplacebo tablet or syrup 3 days/week
Drug:azithromycinazithromycin 3 days/week
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
azithromycinazithrimycin 3 days/week
placeboplacebo 3 days/week
Start Date: August 2009
Completed Date: December 2015
Primary Outcome: frequence of acute sinusitis during 12 mouths of study period
Study sponsors, principal investigator, and references
Principal Investigator: Orathai - Piboonpocanun, MD
Lead Sponsor: Mahidol University