To determine the benefits and harms of discontinuing unnecessary antibiotic therapy for uncomplicated respiratory tract infections (RTI) when antibiotics are considered no longer necessary.
Multicentre, open-label, randomised controlled clinical trial in primary care centres from 2017 to 2020 (, NCT02900820). Adults with RTIs – acute rhinosinusitis, sore throat, influenza, or acute bronchitis – who had previously taken any dose of antibiotic for less than 3 days, which physicians no longer deem necessary were recruited. The patients were randomly assigned in a 1:1 ratio to discontinuing antibiotic therapy or the usual strategy of continuing antibiotic treatment. The primary outcome was the duration of severe symptoms (number of days scoring 5 or 6 on a 6-item Likert scale). Secondary outcomes included days with symptoms, moderate symptoms (scores of 3 or 4), antibiotics taken, adverse events, patient satisfaction, and complications within the first 3 months.
A total of 463 patients were randomised, out of which 409 were considered valid for the analysis. The mean (SD) duration of severe symptoms was 3.0 (1.5) days for the patients assigned to discontinuation and 2.8 (1.3) days for those allocated to the control group (mean difference, 0.2 days [95%CI -0.1-0.4 days]). Patients randomised to the discontinuation group used fewer antibiotics after the baseline visit (52/207 [25.1%] vs 182/202 [90.1%]; P=0.001). Patients assigned to antibiotic continuation presented a relative risk (RR) of adverse events of 1.47 (95% CI 0.80-2.71), but the need for further health care contact in the following 3 months was slightly lower (RR 0.61 [95% CI 0.28-1.37]).
Discontinuing antibiotic treatment for uncomplicated RTIs when clinicians consider it unnecessary is safe and notably reduces antibiotic consumption.

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