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 major component of the treatment regime. The objective of the present study was to compare the effectiveness of a 3-day course of azithromycin and a 2-week course of amoxycillin/clavulanate in the treatment of subacute childhood rhinosinusitis. Methodology: A randomized single-blinded control study of subacute rhinosinusitis was conducted, comparing a 3-day course of azithromycin and a 2-week course of amoxycillin/clavulanate. Inclusion criteria were children aged between 5 and 16 years, duration of nasal blockage or discharge between 30 and 120 days, and abnormal sinus radiographs. All enrolled children were prescribed budesonide nasal spray (Rhinocort Aqua Nasal Spray, Astra Pharmaceuticals, 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%CI 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 between 14 days of amoxycillin/clavulanate and 3 days of azithromycin. Larger studies will be needed to determine which, if any, antibiotic regimen should be used in treating subacute childhood rhinosinusitis.