About: A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards

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About: A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards
Creator	Fowler, Robert Reynolds, Steven Daneman, Nick Hall, Richard Rishu, Asgar Arabi, Yaseen Pinto, Ruxandra Cook, Deborah Muscedere, John Parke, Rachael Belley-Cote, Emilie Mcguinness, Shay Whitlock, Richard Cirone, Robert Downing, Mark Rogers, Benjamin Shehabi, Yahya Shin, Phillip Mcintyre, Lauralyn
Source	PMC
abstract	BACKGROUND: The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. We performed this BALANCE-Ward pilot RCT to examine the feasibility and impact of potentially extending the BALANCE main RCT to include patients hospitalized on non-ICU wards. METHODS: We conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. The co-primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. We compared feasibility outcomes, patient/pathogen characteristics, and overall outcomes among those enrolled in this BALANCE-Ward and prior BALANCE-ICU pilot RCTs. We estimated the sample size and non-inferiority margin impacts of expanding the BALANCE main RCT to include non-ICU patients. RESULTS: A total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1–4.4 patients/site-month). The overall recruitment rate exceeded the BALANCE-ICU pilot RCT (mean 1.10 patients/site-month, p < 0.0001). Overall protocol adherence also exceeded the adherence in the BALANCE-ICU pilot RCT (125/134, 93% vs 89/115, 77%, p = 0.0003). BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection. The BALANCE-Ward pilot RCT patients had an overall 90-day mortality rate of 17/133 (12.8%), which was comparable to the 90-day mortality rate in the ICU pilot RCT (17/115, 14.8%) (p = 0.65). Simulation models indicated there would be minimal sample size and non-inferiority margin implications of expanding enrolment to increasing proportions of non-ICU versus ICU patients. CONCLUSION: It is feasible to enroll non-ICU patients in a trial of 7 versus 14 days of antibiotics for bloodstream infection, and expanding the BALANCE RCT hospital-wide has the potential to improve the timeliness and generalizability of trial results. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02917551. Registered on September 28, 2016.
has issue date	2020-01-15(xsd:dateTime)
bibo:doi	10.1186/s13063-019-4033-9
bibo:pmid	31941546
has license	cc-by
sha1sum (hex)	7dc4da6714344441be18066c318a9e1dc6a6a1fc
schema:url	https://doi.org/10.1186/s13063-019-4033-9
resource representing a document's title	A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards
has PubMed Central identifier	PMC6964073
has PubMed identifier	31941546
schema:publication	Trials
resource representing a document's body	covid:7dc4da6714344441be18066c318a9e1dc6a6a1fc#body_text
is schema:about of	named entity 'performed' named entity 'pilot' named entity 'determined' named entity 'intensive care' named entity 'IMPACT' named entity 'DETERMINED' named entity 'EFFECTIVENESS' named entity 'CLINICAL' named entity 'NON-' named entity 'TO EXAMINE' named entity 'BACKGROUND' named entity 'WARD' named entity 'PATIENTS' named entity 'TREATMENT' covid:arg/7dc4da6714344441be18066c318a9e1dc6a6a1fc named entity 'optimal' named entity 'RCT' named entity 'intensive care unit (ICU)' named entity 'pilot' named entity 'Bacteremia' named entity 'RCT' named entity 'Clinical Effectiveness' named entity 'bloodstream infection' named entity 'critically ill patients' named entity 'pathogenic bacterium' named entity 'general hospital' named entity 'ICU' named entity 'ICU' named entity 'ICU' named entity 'ICU' named entity 'RCT' named entity 'antibiotic' named entity 'mortality rate' named entity 'ClinicalTrials.gov' named entity 'RCT' named entity 'Kingston General Hospital' named entity 'RCT' named entity 'RCT' named entity 'coprimary' named entity 'pathogens' named entity 'ICU' named entity 'subgroup analyses' named entity 'clinician' named entity 'nosocomial infections' named entity 'RCT' named entity 'clinical equipoise' named entity 'ICU' named entity 'hospital discharge' named entity 'ICU' named entity 'antibiotic resistant' named entity 'pathogens' named entity 'World Health Organization' named entity 'RCT' named entity 'infection' named entity 'ICUs' named entity 'ICU' named entity 'Treatment adherence' named entity 'myocardial infarction' named entity 'RCT' named entity 'mortality rate' named entity 'pathogen' named entity 'bacteremic' named entity 'mortality rate'

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