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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?

Sinusitis

Study Interventions

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

Study Arms

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

Study Status

Completed

Start Date: August 2009

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: frequence of acute sinusitis during 12 mouths of study period

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Orathai - Piboonpocanun, MD

Lead Sponsor: Mahidol University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00944515

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