7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial

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dc.contributor.author Daneman, Nick
dc.contributor.author Rishu, Asgar H
dc.contributor.author Pinto, Ruxandra
dc.contributor.author Aslanian, Pierre
dc.contributor.author Bagshaw, Sean M
dc.contributor.author Carignan, Alex
dc.contributor.author Charbonney, Emmanuel
dc.contributor.author Coburn, Bryan
dc.contributor.author Cook, Deborah J
dc.contributor.author Detsky, Michael E
dc.contributor.author Dodek, Peter
dc.contributor.author Hall, Richard
dc.contributor.author Kumar, Anand
dc.contributor.author Lamontagne, Francois
dc.contributor.author Lauzier, Francois
dc.contributor.author Marshall, John C
dc.contributor.author Martin, Claudio M
dc.contributor.author McIntyre, Lauralyn
dc.contributor.author Muscedere, John
dc.contributor.author Reynolds, Steven
dc.contributor.author Sligl, Wendy
dc.contributor.author Stelfox, Henry T
dc.contributor.author Wilcox, M. E
dc.contributor.author Fowler, Robert A
dc.date.accessioned 2018-03-19T16:16:08Z
dc.date.available 2018-03-19T16:16:08Z
dc.date.issued 2018-02-17
dc.identifier.citation Trials. 2018 Feb 17;19(1):111
dc.identifier.uri http://dx.doi.org/10.1186/s13063-018-2474-1
dc.identifier.uri http://hdl.handle.net/1993/32908
dc.description.abstract Abstract Background Shorter-duration antibiotic treatment is sufficient for a range of bacterial infections, but has not been adequately studied for bloodstream infections. Our systematic review, survey, and observational study indicated equipoise for a trial of 7 versus 14 days of antibiotic treatment for bloodstream infections; a pilot randomized clinical trial (RCT) was a necessary next step to assess feasibility of a larger trial. Methods We conducted an open, pilot RCT of antibiotic treatment duration among critically ill patients with bloodstream infection across 11 intensive care units (ICUs). Antibiotic selection, dosing and route were at the discretion of the treating team; patients were randomized 1:1 to intervention arms consisting of two fixed durations of treatment – 7 versus 14 days. We recruited adults with a positive blood culture yielding pathogenic bacteria identified while in ICU. We excluded patients with severe immunosuppression, foci of infection with an established requirement for prolonged treatment, single cultures with potential contaminants, or cultures yielding Staphylococcus aureus or fungi. The primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. Secondary outcomes included 90-day, ICU and hospital mortality, relapse of bacteremia, lengths of stay, mechanical ventilation and vasopressor duration, antibiotic-free days, Clostridium difficile, antibiotic adverse events, and secondary infection with antimicrobial-resistant organisms. Results We successfully achieved our target sample size (n = 115) and average recruitment rate of 1 (interquartile range (IQR) 0.3–1.5) patient/ICU/month. Adherence to treatment duration was achieved in 89/115 (77%) patients. Adherence differed by underlying source of infection: 26/31 (84%) lung; 18/29 (62%) intra-abdominal; 20/26 (77%) urinary tract; 8/9 (89%) vascular-catheter; 4/4 (100%) skin/soft tissue; 2/4 (50%) other; and 11/12 (92%) unknown sources. Patients experienced a median (IQR) 14 (8–17) antibiotic-free days (of the 28 days after blood culture collection). Antimicrobial-related adverse events included hepatitis in 1 (1%) patient, Clostridium difficile infection in 4 (4%), and secondary infection with highly resistant microorganisms in 10 (9%). Ascertainment was complete for all study outcomes in ICU, in hospital and at 90 days. Conclusion It is feasible to conduct a RCT to determine whether 7 versus 14 days of antibiotic treatment is associated with comparable 90-day survival. Trial registration ClinicalTrials.gov , identifier: NCT02261506 . Registered on 26 September 2014.
dc.title 7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial
dc.type Journal Article
dc.language.rfc3066 en
dc.rights.holder The Author(s).
dc.date.updated 2018-03-01T06:52:13Z

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