Preemptive Prevention Bundle for C. Difficile

Overseen By Sanjat Kanjilal, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Non-carriers, Non-ICU, Non-oncology

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on preventing C. difficile infections, particularly in individuals who carry the bacteria without symptoms. It tests a special prevention package, the Preemptive C. difficile Infection Prevention Bundle, which includes enhanced room cleaning and careful antibiotic management, among other measures. The trial compares two groups: those receiving this prevention package and those receiving standard care. It seeks patients in ICU or Oncology units who carry C. difficile. As an unphased trial, this study provides a unique opportunity to contribute to innovative prevention strategies that could benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prevention bundle is safe for patients?

Research shows that the preemptive prevention bundle for C. difficile is designed to be safe for people. This approach includes enhanced room cleaning and a pharmacist's review to optimize antibiotic and antacid use. It also considers vancomycin as a preventative treatment to stop infection.

Studies have shown that similar bundles aim to reduce infections without causing harm. These interventions focus on small changes in hospital practices, which patients generally tolerate well. Improved cleaning and careful medication review have not shown significant negative effects in other research.

While specific data on this bundle's safety isn't detailed in the sources, the components are based on strategies safely used in healthcare settings. This suggests that the prevention bundle is likely to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the preemptive prevention bundle for C. difficile because it takes a proactive approach to infection control that goes beyond the standard care. Unlike typical treatments that focus on addressing an active infection, this bundle aims to prevent infections from occurring in the first place. The bundle includes enhanced room cleaning, specific C. difficile precautions, pharmacist-led optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis. By targeting the environment and medication regimens before an infection sets in, the prevention bundle could significantly reduce the incidence of C. difficile infections, offering a new layer of protection for patients.

What evidence suggests that the Preemptive C. difficile infection prevention bundle is effective for preventing C. difficile infections?

Research has shown that preventing infections before they start can significantly reduce the risk of C. difficile infections. In this trial, one group of patients colonized with toxigenic C. difficile will receive a preemptive prevention bundle. This bundle includes enhanced room cleaning, C. difficile precautions, pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis. Studies have found that identifying asymptomatic carriers and using specific prevention methods, such as improved cleaning and careful antibiotic use, can lower infection rates. For instance, a program using these methods reduced hospital-related C. difficile infections over 28 months. Early results from various hospitals show promising reductions in infection rates, supporting the effectiveness of these methods. ^{1 3 4 6 7}

Who Is on the Research Team?

Meghan A Baker, MD, SCD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for patients in ICU or oncology units who have been identified as carriers of C. difficile through a VRE swab test. It excludes those not carrying C. difficile and patients outside the ICU or oncology units.

Inclusion Criteria

I am in the ICU or Oncology unit and tested positive for C. Difficile.

Exclusion Criteria

I am not currently in the ICU or an oncology unit.

I do not carry the C. difficile bacteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a preemptive prevention bundle for asymptomatic C. difficile carriers, including enhanced room cleaning, C. difficile precautions, pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis.

24 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, focusing on the incidence rate of C. difficile infection.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Preemptive C. difficile infection prevention bundle

Trial Overview The study compares routine care with a preemptive prevention bundle designed to stop asymptomatic carriers from developing active C. difficile infections and prevent them from transmitting it to others.

How Is the Trial Designed?

Group I: Patients colonized with toxigenic C. difficile who do not receive the prevention bundle Active Control 1 Intervention

Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive standard of care

Group II: Patients colonized with toxigenic C. difficile who receive the prevention bundle Active Control 1 Intervention

Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive a preemptive prevention bundle for C. difficile including enhanced room cleaning, C. difficile precautions, pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Harvard Pilgrim Health Care Institute

Collaborator

Trials

2

Recruited

3,100+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Massachusetts Host-Microbiome Center

Collaborator

Trials

1

Recruited

300+

Hatch Family Foundation

Collaborator

Trials

1

Recruited

300+

Published Research Related to This Trial

The development of a vaccine against Clostridium difficile infection (CDI) shows promise, as computer simulation models indicate it could be cost-effective for patients at risk of CDI and for preventing recurrence after treatment.

The vaccine's cost-effectiveness is particularly notable when used after CDI treatment, suggesting it could significantly reduce the risk of recurrent infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential value of Clostridium difficile vaccine: an economic computer simulation model. Lee, BY., Popovich, MJ., Tian, Y., et al.[2021]

Clostridioides difficile is a major cause of infections in healthcare settings, and preventing these infections requires a combination of strategies, including strict hygiene practices and environmental cleaning.

Current understanding of C. difficile transmission is complex, and while some interventions like probiotics and managing proton pump inhibitors are suggested, their effectiveness is not well established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital Infection Control: Clostridioides difficile. Turner, NA., Anderson, DJ.[2021]

The most effective strategy to reduce hospital-onset Clostridioides difficile infections (CDI) in a simulated pediatric hospital was a combination of daily environmental disinfection with a sporicidal product and screening for asymptomatic C. difficile at admission, leading to a 62% reduction in CDI and an 88.4% reduction in asymptomatic colonization.

Other single interventions, such as daily disinfection and hand hygiene among healthcare workers and patients, also contributed to reducing CDI rates, but visitor hand hygiene and contact precautions were found to be ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing C. difficile in children: An agent-based modeling approach to evaluate intervention effectiveness. Barker, AK., Scaria, E., Alagoz, O., et al.[2021]

The implementation of a Clostridium difficile infection (CDI) bundle, which included enhanced cleaning practices and education, significantly reduced CDI incidence from 11.2 to 4.8 per 1000 admissions over a period from 2009 to 2014.

Probiotic use among patients receiving antibiotics was associated with a further decrease in CDI incidence from 2.2% to 0.7%, suggesting that probiotics may enhance the effectiveness of CDI prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Institutional review of the implementation and use of a Clostridium difficile infection bundle and probiotics in adult trauma patients. Bommiasamy, AK., Connelly, C., Moren, A., et al.[2019]

A pilot study of a bundled intervention to reduce Clostridioides difficile Infection (CDI) at two hospitals showed that while both hospitals reduced the use of proton-pump inhibitors and high-risk antibiotics, only one hospital effectively decreased inappropriate CDI testing and saw a significant 75% reduction in hospital-onset CDI after implementation.

The variable effectiveness of the CDI reduction bundle highlights the importance of measuring compliance with individual intervention components, as differences in uptake may explain the varying outcomes between the two hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a C. difficile infection (CDI) reduction bundle and its components on CDI diagnosis and prevention. Blanco, N., Robinson, GL., Heil, EL., et al.[2021]

A qualitative study involving focus groups of environmental services staff, physicians, and nurses identified key barriers to implementing a Clostridioides difficile infection (CDI) prevention bundle, including inconsistent knowledge of procedures and increased workload.

The study highlighted the importance of a systems engineering approach to address conflicting needs between healthcare providers, such as the need for rapid patient placement versus thorough environmental disinfection, to improve CDI management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Clostridioides difficile prevention bundle: Understanding common, unique, and conflicting work system barriers and facilitators for subprocess design. Musuuza, JS., Hundt, AS., Carayon, P., et al.[2020]

A collaborative approach involving 35 hospitals in the New York metropolitan area successfully implemented infection prevention and cleaning protocols, leading to a significant reduction in hospital-onset Clostridium difficile infections (CDI).

The intervention included standardized protocols, regular data monitoring, and interdisciplinary teamwork, demonstrating that coordinated efforts can effectively lower CDI rates in acute care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of hospital-onset Clostridium difficile infection in the New York metropolitan region using a collaborative intervention model. Koll, BS., Ruiz, RE., Calfee, DP., et al.[2020]

A systematic review of 26 studies found that all reported improvements in Clostridium difficile infection (CDI) rates after implementing various bundled interventions, although the details on adherence and implementation were often incomplete.

Due to the absence of randomized controlled trials, it is currently impossible to establish a direct causal relationship between these bundled interventions and the observed reductions in CDI rates, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Clostridium difficile in the Inpatient Setting: A Systematic Review of the Adherence to and Effectiveness of C. difficile Prevention Bundles. Barker, AK., Ngam, C., Musuuza, JS., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10973890/

CDC's Hospital-Onset Clostridioides difficile Prevention ... This quality improvement study investigates whether implementation of the Centers for Disease Control and Prevention's Strategies to Prevent Clostridioides ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05389904

Study Details | NCT05389904 | Pre-emptive Prevention for ... This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835226

Clostridioides difficile Infection Prevention in a Hospital ... This quality improvement study examines a 28-month quality improvement program that used an institution-specific AI model to guide ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555532/

Clostridioides difficile Infection - Making Healthcare Safer III Therefore, to address C. difficile prevention, this report dedicates an entire chapter to CDI PSPs; in the last report, much of the information on HAI PSPs was ...

5. apic.org apic.org/Resource_/TinyMceFileManager/Practice_Guidance/cdiff/C.Diff_Digital_Toolkit_GNYHA.pdf

REDUCING C. DIFFICILE INFECTIONS TOOLKIT This toolkit is based on published guidelines and the experiences of the facili- ties that participated in the GNYHA/UHF C. difficile Collaborative.

6. withpower.com withpower.com/trial/phase-c-difficile-colonization-5-2022-fd97e

Preemptive Prevention Bundle for C. Difficile This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package ...

7. shea-online.org shea-online.org/unpacking-the-c-difficile-infection-prevention-bundle/

Unpacking the C. difficile infection prevention bundle The five components of this CDI reduction bundle were: Timely placement of enteric precautions; Decision support at the time of electronic ordering; Reducing ...