Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteraemia (SAFE trial): protocol for a randomised, controlled, open-label, non-inferiority trial comparing 4 and 6 weeks of antibiotic treatment

Autor: DTP Buis, CH van Werkhoven, MA van Agtmael, HI Bax, M Berrevoets, MGJ de Boer, MJM Bonten, JE Bosmans, J Branger, S Douiyeb, LBS Gelinck, E Jong, AJJ Lammers, JTM Van der Meer, JJ Oosterheert, E Sieswerda, R Soetekouw, JE Stalenhoef, TW Van der Vaart, EA Bij de Vaate, NJ Verkaik, MGA Van Vonderen, PJ De Vries, JM Prins, KCE Sigaloff
Přispěvatelé: Infectious diseases, AII - Infectious diseases, Health Economics and Health Technology Assessment, APH - Mental Health, APH - Methodology, Internal medicine, AII - Inflammatory diseases, Psychiatry, Gastroenterology and hepatology, VU University medical center, Medical Microbiology & Infectious Diseases, Internal Medicine, Pathology
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMJ open, 13(4):e068295. BMJ Publishing Group
BMJ Open, 13(4):e068295, 1-26. BMJ Publishing Group
Collaborators SAFE-trial study group 2023, ' Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteraemia (SAFE trial) : protocol for a randomised, controlled, open-label, non-inferiority trial comparing 4 and 6 weeks of antibiotic treatment ', BMJ Open, vol. 13, no. 4, e068295, pp. e068295 . https://doi.org/10.1136/bmjopen-2022-068295
BMJ Open, 13(4). BMJ Publishing Group
BMJ Open, 13(4):e068295. BMJ Publishing Group
Buis, D T P, Van Werkhoven, C H, Van Agtmael, M A, Bax, H I, Berrevoets, M, De Boer, M G J, Bonten, M J M, Bosmans, J E, Branger, J, Douiyeb, S, Gelinck, L B S, Jong, E, Lammers, A J J, Van Der Meer, J T M, Oosterheert, J J, Sieswerda, E, Soetekouw, R, Stalenhoef, J E, Van Der Vaart, T W, Bij De Vaate, E A, Verkaik, N J, Van Vonderen, M G A, De Vries, P J, Prins, J M & Sigaloff, K C E 2023, ' Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteraemia (SAFE trial) : Protocol for a randomised, controlled, open-label, non-inferiority trial comparing 4 and 6 weeks of antibiotic treatment ', BMJ Open, vol. 13, no. 4, e068295, pp. 1-26 . https://doi.org/10.1136/bmjopen-2022-068295
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2022-068295
Popis: IntroductionA major knowledge gap in the treatment of complicatedStaphylococcus aureusbacteraemia (SAB) is the optimal duration of antibiotic therapy. Safe shortening of antibiotic therapy has the potential to reduce adverse drug events, length of hospital stay and costs. The objective of the SAFE trial is to evaluate whether 4 weeks of antibiotic therapy is non-inferior to 6 weeks in patients with complicated SAB.Methods and analysisThe SAFE-trial is a multicentre, non-inferiority, open-label, parallel group, randomised controlled trial evaluating 4 versus 6 weeks of antibiotic therapy for complicated SAB. The study is performed in 15 university hospitals and general hospitals in the Netherlands. Eligible patients are adults with methicillin-susceptible SAB with evidence of deep-seated or metastatic infection and/or predictors of complicated SAB. Only patients with a satisfactory clinical response to initial antibiotic treatment are included. Patients with infected prosthetic material or an undrained abscess of 5 cm or more at day 14 of adequate antibiotic treatment are excluded. Primary outcome is success of therapy after 180 days, a combined endpoint of survival without evidence of microbiologically confirmed disease relapse. Assuming a primary endpoint occurrence of 90% in the 6 weeks group, a non-inferiority margin of 7.5% is used. Enrolment of 396 patients in total is required to demonstrate non-inferiority of shorter antibiotic therapy with a power of 80%. Currently, 152 patients are enrolled in the study.Ethics and disseminationThis is the first randomised controlled trial evaluating duration of antibiotic therapy for complicated SAB. Non-inferiority of 4 weeks of treatment would allow shortening of treatment duration in selected patients with complicated SAB. This study is approved by the Medical Ethics Committee VUmc (Amsterdam, the Netherlands) and registered under NL8347 (the Netherlands Trial Register). Results of the study will be published in a peer-reviewed journal.Trial registration numberNL8347 (the Netherlands Trial Register).
Databáze: OpenAIRE
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