Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

Mahidol University

Status: Completed

Conditions: Sinusitis

Treatments: Drug: azithromycin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00944515

394/2551(EC4)

Details and patient eligibility

About

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

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

azithromycin

Active Comparator group

Description:

azithrimycin 3 days/week

Treatment:

Drug: azithromycin

placebo

Placebo Comparator group

Description:

placebo 3 days/week

Treatment:

Drug: placebo