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Screening to Prophylax against C. difficile Infection (StoP CDI)

Award Number: R01HS024951
ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY
OPDIV: AHRQ
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2016
PERIOD OF PERFORMANCE END DATE: 08/31/2023

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Screening to Prophylax against C. difficile Infection (StoP CDI) - Abstract Clostridium difficile infection (CDI) is the most common healthcare-associated infection (HAI), accounting for 12% of all HAIs. The Centers for Disease Control and Prevention has labeled CDI as one of three urgent health threats that require immediate and aggressive action, as CDI is responsible for more than 450,000 hospitalizations and 29,000 deaths per year. Patients over 65 years old are most commonly affected and have the highest mortality. C. difficile causes disease through production of toxins, and the increase in incidence, severity, and mortality is in part due to the spread of a hypervirulent strain (NAP/BI/027) that produces more toxin. Pre-existing colonization with toxigenic C. difficile is a risk factor for developing CDI. Use of antibiotics that disrupt the protective normal colonic flora is the single largest risk factor for both C. difficile colonization and CDI. Current strategies to prevent CDI involve infection control measures to prevent transmission of C. difficile and antibiotic stewardship to control antibiotic use. Ultimately, however, infection control cannot prevent cases of CDI in patients already colonized. Thus, new measures need to be developed to identify patients at risk for CDI due to toxigenic colonization and prevent progression to disease. To date, no studies have considered primary prophylaxis as an approach to preventing CDI in appropriate patients, despite the fact that prophylaxis is a universally accepted method of preventing other diverse infections. In this study, we propose to screen patients who are initiating a course of antibiotics considered high risk for CDI to determine who is colonized with toxigenic C. difficile and, therefore, at risk of developing CDI. We hypothesize that the most effective and affordable intervention in the colonized patient population is prophylactic treatment with vancomycin, which is efficacious against C. difficile. Our goal for this study is to implement a first-of-its-kind clinical trial with the following specific aims: 1) Determine the prevalence of toxigenic C. difficile colonization among the inpatient population treated with high-risk antibiotics and the incidence of CDI in these patients with respect to their state of colonization with C. difficile; and 2) Determine the effect of vancomycin prophylaxis on patients receiving high-risk antibiotics who are colonized with toxigenic C. difficile based on molecular testing. This clinical trial has the potential to cause transformative change in the methodology of preventing CDI and alter the standard of care when using high-risk antibiotics in the hospital setting. This is a significant contribution; this cost effective and easily implemented intervention has the potential to reverse the increasing incidence of CDI and associated mortality rates, decrease the economic burden associated with the disease, and improve patient quality of life with minimal discomfort and adverse impact to patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$131,044 )
2024	2020	WILLIAM BEAUMONT HOSPITAL	26901 BEAUMONT BLVD # 6D	SOUTHFIELD	MI	48033	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	12/6/2023	NON-COMPETING CONTINUATION	-$131,044
														Subtotal = -$131,044

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	WILLIAM BEAUMONT HOSPITAL	3601 W 13 MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	3/3/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	WILLIAM BEAUMONT HOSPITAL	3601 W 13 MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	8/30/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	WILLIAM BEAUMONT HOSPITAL	3601 W. THIRTEEN MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	001	5	9/20/2021	NON-COMPETING CONTINUATION	$0
2021	2020	WILLIAM BEAUMONT HOSPITAL	3601 W. THIRTEEN MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	7/2/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $453,298 )
2020	2020	WILLIAM BEAUMONT HOSPITAL	3601 W. THIRTEEN MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	001	5	8/26/2020	NON-COMPETING CONTINUATION	$453,298
2020	2018	WILLIAM BEAUMONT HOSPITAL	3601 W. THIRTEEN MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	000	3	3/24/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $453,298

Issue Date FY: 2019 ( Subtotal = $486,595 )
2019	2019	WILLIAM BEAUMONT HOSPITAL	3601 W. THIRTEEN MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	000	4	9/16/2019	NON-COMPETING CONTINUATION	$486,595
														Subtotal = $486,595

Issue Date FY: 2018 ( Subtotal = $486,608 )
2018	2018	WILLIAM BEAUMONT HOSPITAL	3601 W. THIRTEEN MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	000	3	8/24/2018	NON-COMPETING CONTINUATION	$486,608
														Subtotal = $486,608

Issue Date FY: 2017 ( Subtotal = $486,621 )
2017	2017	WILLIAM BEAUMONT HOSPITAL	3601 W. THIRTEEN MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	000	2	8/31/2017	NON-COMPETING CONTINUATION	$486,621
														Subtotal = $486,621

Issue Date FY: 2016 ( Subtotal = $473,473 )
2016	2016	WILLIAM BEAUMONT HOSPITAL	3601 W 13 MILE ROAD	ROYAL OAK	MI	48073	OAKLAND	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	9/1/2016	NEW	$473,473
														Subtotal = $473,473

Grand Total All Awards = $2,255,551

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Screening to Prophylax against C. difficile Infection (StoP CDI)

Award Number: R01HS024951

ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY

OPDIV: AHRQ

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2016

PERIOD OF PERFORMANCE END DATE: 08/31/2023

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