Matches in SemOpenAlex for { <https://semopenalex.org/work/W2135039050> ?p ?o ?g. }
Showing items 1 to 84 of
84
with 100 items per page.
- W2135039050 abstract "Introduction CDAD is the most common health care-acquired infection in the United Kingdom and causes significant morbidity and mortality. Previous studies have reported incidences of CDAD as high as 17%. Prevention of CDAD by Probiotics co-administration during antibiotic exposure is an appealing concept, but the few previously published trials showed inconclusive data and were hindered by flaws in trial design. This trial aims to investigate whether VSL#3 will prevent AAD and CDAD in hospitalised patients exposed to systemic antibiotics. Methods This multi-centre, randomised, double-blind, placebo-controlled trial will recruit 445 patients. One sachet of VSL#3 or placebo is given twice daily for the length of the antibiotics course and 7 days thereafter with follow-up for 28 days after the last antibiotic dose. Primary outcomes are occurrence of AAD and CDAD and secondary outcomes are length of stay (LOS) and 30-day mortality. Results This interim analysis reports on 124 patients enrolled in the trial so far. 62 patients were randomised to the active and 62 to the placebo group. Both groups were well matched for baseline demographic patient data. The study drug was generally well tolerated, and there was no difference in the rate of serious adverse events (3 in each group). Exposure to high risk antibiotic regimens was 85.5% (active) and 74.4% (placebo), respectively. No statistically significant differences were found in primary and secondary outcomes between the active and the placebo group at interim analysis. There was, however, a trend towards less AAD in the active group on per protocol analysis (active 0%, placebo 11.4%, p = 0.11). Assuming CDAD incidences of 5% in the placebo group and 0.1% in the active group 175 participants per group (350 in total) would give 90% power to detect a difference at a significance level of 0.05. Conclusion VSL#3 is well tolerated, and no drug-related SAE were reported. The incidences of both AAD and CDAD are much lower than previously reported. This may reflect improved infection control measures (hygiene, isolation rooms, and antibiotic policy) at the participating sites. Updated power calculations based on the lower incidences find that the original sample size is still suitable to confirm or refute the primary hypothesis." @default.
- W2135039050 created "2016-06-24" @default.
- W2135039050 creator A5016638065 @default.
- W2135039050 creator A5036877248 @default.
- W2135039050 creator A5041223814 @default.
- W2135039050 creator A5049199110 @default.
- W2135039050 creator A5076631930 @default.
- W2135039050 date "2011-03-13" @default.
- W2135039050 modified "2023-09-26" @default.
- W2135039050 title "VSL#3 for the prevention of antibiotic associated diarrhoea (AAD) and clostridium difficile associated diarrhoea (CDAD): an interim analysis" @default.
- W2135039050 doi "https://doi.org/10.1136/gut.2011.239301.7" @default.
- W2135039050 hasPublicationYear "2011" @default.
- W2135039050 type Work @default.
- W2135039050 sameAs 2135039050 @default.
- W2135039050 citedByCount "6" @default.
- W2135039050 countsByYear W21350390502012 @default.
- W2135039050 countsByYear W21350390502013 @default.
- W2135039050 countsByYear W21350390502015 @default.
- W2135039050 crossrefType "journal-article" @default.
- W2135039050 hasAuthorship W2135039050A5016638065 @default.
- W2135039050 hasAuthorship W2135039050A5036877248 @default.
- W2135039050 hasAuthorship W2135039050A5041223814 @default.
- W2135039050 hasAuthorship W2135039050A5049199110 @default.
- W2135039050 hasAuthorship W2135039050A5076631930 @default.
- W2135039050 hasBestOaLocation W21350390501 @default.
- W2135039050 hasConcept C126322002 @default.
- W2135039050 hasConcept C142724271 @default.
- W2135039050 hasConcept C166957645 @default.
- W2135039050 hasConcept C168563851 @default.
- W2135039050 hasConcept C197934379 @default.
- W2135039050 hasConcept C204787440 @default.
- W2135039050 hasConcept C27081682 @default.
- W2135039050 hasConcept C2776957806 @default.
- W2135039050 hasConcept C2779802037 @default.
- W2135039050 hasConcept C2994496256 @default.
- W2135039050 hasConcept C501593827 @default.
- W2135039050 hasConcept C61943457 @default.
- W2135039050 hasConcept C71924100 @default.
- W2135039050 hasConcept C86803240 @default.
- W2135039050 hasConcept C89423630 @default.
- W2135039050 hasConcept C95457728 @default.
- W2135039050 hasConceptScore W2135039050C126322002 @default.
- W2135039050 hasConceptScore W2135039050C142724271 @default.
- W2135039050 hasConceptScore W2135039050C166957645 @default.
- W2135039050 hasConceptScore W2135039050C168563851 @default.
- W2135039050 hasConceptScore W2135039050C197934379 @default.
- W2135039050 hasConceptScore W2135039050C204787440 @default.
- W2135039050 hasConceptScore W2135039050C27081682 @default.
- W2135039050 hasConceptScore W2135039050C2776957806 @default.
- W2135039050 hasConceptScore W2135039050C2779802037 @default.
- W2135039050 hasConceptScore W2135039050C2994496256 @default.
- W2135039050 hasConceptScore W2135039050C501593827 @default.
- W2135039050 hasConceptScore W2135039050C61943457 @default.
- W2135039050 hasConceptScore W2135039050C71924100 @default.
- W2135039050 hasConceptScore W2135039050C86803240 @default.
- W2135039050 hasConceptScore W2135039050C89423630 @default.
- W2135039050 hasConceptScore W2135039050C95457728 @default.
- W2135039050 hasLocation W21350390501 @default.
- W2135039050 hasOpenAccess W2135039050 @default.
- W2135039050 hasPrimaryLocation W21350390501 @default.
- W2135039050 hasRelatedWork W1587944958 @default.
- W2135039050 hasRelatedWork W1918085057 @default.
- W2135039050 hasRelatedWork W1925194624 @default.
- W2135039050 hasRelatedWork W1954829662 @default.
- W2135039050 hasRelatedWork W1994689525 @default.
- W2135039050 hasRelatedWork W1996782933 @default.
- W2135039050 hasRelatedWork W2013446759 @default.
- W2135039050 hasRelatedWork W2043406878 @default.
- W2135039050 hasRelatedWork W2077666564 @default.
- W2135039050 hasRelatedWork W2085950961 @default.
- W2135039050 hasRelatedWork W2121291178 @default.
- W2135039050 hasRelatedWork W2127805721 @default.
- W2135039050 hasRelatedWork W2133970514 @default.
- W2135039050 hasRelatedWork W2137981729 @default.
- W2135039050 hasRelatedWork W2141362163 @default.
- W2135039050 hasRelatedWork W2147619842 @default.
- W2135039050 hasRelatedWork W2147741767 @default.
- W2135039050 hasRelatedWork W2152575922 @default.
- W2135039050 hasRelatedWork W2773489480 @default.
- W2135039050 hasRelatedWork W2968907657 @default.
- W2135039050 isParatext "false" @default.
- W2135039050 isRetracted "false" @default.
- W2135039050 magId "2135039050" @default.
- W2135039050 workType "article" @default.