Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
- Registration Number
- NCT00944515
- Lead Sponsor
- Mahidol University
- Brief Summary
The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing recurrent acute sinusitis in children.
- Detailed Description
A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in preventing recurrent acute sinusitis in children
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo placebo 3 days/week azithromycin azithromycin azithrimycin 3 days/week
- Primary Outcome Measures
Name Time Method frequence of acute sinusitis during 12 mouths of study period 12 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie azithromycin's anti-inflammatory effects in recurrent acute sinusitis (RAS) prevention in pediatric patients?
How does azithromycin prophylaxis compare to standard-of-care antibiotics like amoxicillin-clavulanate in preventing RAS recurrence in children?
Which biomarkers (e.g., IL-6, C-reactive protein) predict response to azithromycin prophylaxis in NCT00944515 pediatric sinusitis trials?
What are the long-term safety profiles of azithromycin prophylaxis in children, particularly regarding gastrointestinal or cardiac adverse events?
How does azithromycin's efficacy in RAS prevention compare to combination therapies with nasal corticosteroids or other macrolides like clarithromycin?
Trial Locations
- Locations (1)
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
🇹🇭Bangkok, Thailand
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University🇹🇭Bangkok, Thailand