A randomized controlled trial of azithromycin and amoxycillin/clavulanate in the management of subacute childhood rhinosinusitis

Objective: Subacute childhood rhinosinusitis is a disorder commonly seen in children with allergic rhinitis. Antibiotics have been recommended as a ma jor component of the treatment regime. The objective of the present study w as to compare the effectiveness of a 3-day course of azithromycin and a 2-w eek course of amoxycillin/clavulanate in the treatment of subacute childhoo d rhinosinusitis. Methodology: A randomized single-blinded control study of subacute rhinosin usitis was conducted, comparing a 3-day course of azithromycin and a 2-week course of amoxycillin/clavulanate. Inclusion criteria were children aged b etween 5 and 16 years, duration of nasal blockage or discharge between 30 a nd 120 days, and abnormal sinus radiographs. All enrolled children were pre scribed budesonide nasal spray (Rhinocort Aqua Nasal Spray, Astra Pharmaceu ticals, Sodertalje, Sweden) as adjuvant treatment. Results: Forty-two children were recruited into the study and one defaulted on follow-up. Failure occurred in 6 of 20 for the azithromycin group and 5 of 21 for the amoxycillin/clavulanate group. The odds ratio was 1.46 (95%C I 0.37-5.80, P = 0.73). No relapse occurred in azithromycin group and 5 of 21 in amoxycillin/clavulanate group. The odds ratio was 0.16 (95%CI 0.017-1 .51, P=0.18). Both antibiotics were well tolerated, however, two children, one from each group, complained of mild transient epigastric discomfort. Conclusions: This small study did not provide evidence of a difference betw een 14 days of amoxycillin/clavulanate and 3 days of azithromycin. Larger s tudies will be needed to determine which, if any, antibiotic regimen should be used in treating subacute childhood rhinosinusitis.