To investigate whether 6 days of antibiotic treatment duration is non-inferior to 12 days in patients hospitalised for cellulitis” Cranendonk et al(2019).
Objectives: To investigate whether 6 days of antibiotic treatment duration is non-inferior to 12 days in patients hospitalised for cellulitis.
Methods: This multicentre, randomised, double-blind, placebo-controlled, non-inferiority trial enrolled adult patients hospitalised for severe cellulitis who were treated with intravenous flucloxacillin. At day 6 participants with symptom improvement who were afebrile were randomised between an additional 6 days of oral flucloxacillin or placebo in a 1:1 ratio, stratified for diabetes and hospital. The primary outcome was cure by day 14, without relapse by day 28. Secondary outcomes included a modified cure assessment and relapse rate by day 90.
Results: Between August 2014 and June 2017, 151 of 248 included participants were randomised. The intention-to-treat population consisted of 76 and 73 participants allocated to 12 and 6 days antibiotic therapy, respectively (mean age 62 years, 67% males, 24% diabetics). 38/76 (50.0%) and 36/73 (49.3%) were cured in the 12- and 6-day groups (ARR 0.7 percentage points, 95% CI: -15.0 to 16.3). Cure rates were 56/76 (73.7%) and 49/73 (67.1%) with the modified cure assessment (ARR 6.6, 95% CI: -8.0 to 20.8). After initial cure without relapse, day 90 relapse rates were higher in the 6-day group (6% vs 24%, p<0.05). Conclusions: Given the wide confidence intervals, we can neither confirm nor refute our hypothesis that 6 days of therapy is non-inferior to 12 days of therapy. However, a 6-day course resulted in significantly more frequent relapses by day 90. These findings require confirmation in future studies.
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Cranendonk, D.R., Opmeer, B.C., van Agtmael, M.A., Branger, J., Brinkman, K., Hoepelman, A.I.M., Lauw, F.N., Oosterheert, J.J., Pijlman, A.H., Sankatsing, S.U.C., Soetekouw, R., Veenstra, J., de Vries, P.J., Prins, J.M. and Wiersinga, M.J. (2019) Antibiotic treatment for 6 days versus 12 days in patients with severe cellulitis: a multicentre randomised, double-blind, placebo-controlled, non-inferiority trial. Clinical Microbiology and Infection. October 13th. DOI: https://doi.org/10.1016/j.cmi.2019.09.019. .