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1.
Br J Clin Pharmacol ; 87(8): 3075-3091, 2021 08.
Article in English | MEDLINE | ID: mdl-33377218

ABSTRACT

AIMS: Inhaled nebulised unfractionated heparin (UFH) has a strong scientific and biological rationale that warrants urgent investigation of its therapeutic potential in patients with COVID-19. UFH has antiviral effects and prevents the SARS-CoV-2 virus' entry into mammalian cells. In addition, UFH has significant anti-inflammatory and anticoagulant properties, which limit progression of lung injury and vascular pulmonary thrombosis. METHODS: The INHALEd nebulised unfractionated HEParin for the treatment of hospitalised patients with COVID-19 (INHALE-HEP) metatrial is a prospective individual patient data analysis of on-going randomised controlled trials and early phase studies. Individual studies are being conducted in multiple countries. Participating studies randomise adult patients admitted to the hospital with confirmed SARS-CoV-2 infection, who do not require immediate mechanical ventilation, to inhaled nebulised UFH or standard care. All studies collect a minimum core dataset. The primary outcome for the metatrial is intubation (or death, for patients who died before intubation) at day 28. The secondary outcomes are oxygenation, clinical worsening and mortality, assessed in time-to-event analyses. Individual studies may have additional outcomes. ANALYSIS: We use a Bayesian approach to monitoring, followed by analysing individual patient data, outcomes and adverse events. All analyses will follow the intention-to-treat principle, considering all participants in the treatment group to which they were assigned, except for cases lost to follow-up or withdrawn. TRIAL REGISTRATION, ETHICS AND DISSEMINATION: The metatrial is registered at ClinicalTrials.gov ID NCT04635241. Each contributing study is individually registered and has received approval of the relevant ethics committee or institutional review board. Results of this study will be shared with the World Health Organisation, published in scientific journals and presented at scientific meetings.


Subject(s)
COVID-19 , Heparin , Adult , Bayes Theorem , Humans , Prospective Studies , SARS-CoV-2 , Treatment Outcome
2.
Am J Infect Control ; 46(10): 1160-1166, 2018 10.
Article in English | MEDLINE | ID: mdl-29803592

ABSTRACT

BACKGROUND: Clostridium difficile infection (CDI) is associated with significant morbidity and mortality. Computerized clinical decision support (CCDS) tools can aid process improvement in infection prevention and antibiotic stewardship, but implementation and health care workers (HCWs) uptake of these tools is often variable. The objective of this study was to describe HCWs' perceptions of barriers and facilitators related to uptake of CCDS tools as part of a CDI reduction bundle. METHODS: We conducted a qualitative study among HCWs at 2 acute care hospitals in Maryland. Semi-structured interviews and structured surveys were completed by HCWs to evaluate their perception to CCDS tools at 2 different stages: predevelopment and preimplementation. Emergent themes and patterns in the data were identified and condensed. RESULTS: Gaps in CDI-related knowledge and in communication between HCWs were identified throughout the evaluation. HCWs agreed on the potential of the tools to improve CDI diagnosis, prevention, and control. An important barrier for uptake was the perceived loss of autonomy and clinical judgment, whereas standardization and error reduction were perceived advantages. CONCLUSIONS: These observations shaped the development and implementation of the CDI reduction bundle. Qualitative findings can provide valuable contextual information during the development stages of CCDS tools in infection prevention and antibiotic stewardship.


Subject(s)
Attitude of Health Personnel , Clostridium Infections/prevention & control , Decision Support Systems, Clinical , Anti-Bacterial Agents/therapeutic use , Antimicrobial Stewardship , Cross Infection/prevention & control , Drug Utilization/standards , Health Personnel , Hospitals , Humans
3.
Open Forum Infect Dis ; 2(4): ofv142, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26495324

ABSTRACT

Although they are ubiquitous to aquatic environments, Aeromonas species have traditionally been considered nonvirulent; however, in the past 30 years, they have emerged as important human pathogens that can cause a wide spectrum of disease. In this study, we describe a case of recurrent Aeromonas bacteremia in an immunocompetent patient, and this exposure was linked to the patient's home well water supply.

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