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

Trial Summary

What is the purpose of this trial?

Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing \>500,000 infections and \>29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmission to other patients. Recent genomic epidemiology studies, however, suggest that most hospital-onset CDI cases are attributable to asymptomatic carriers who either progress from colonization to active infection themselves or transmit C. difficile to other patients while asymptomatic. This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package to protect the carrier from progression to active infection and to prevent transmission from the carrier to other 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 data supports the effectiveness of the Preemptive C. difficile infection prevention bundle treatment?

Research shows that using bundles of interventions, like the Preemptive C. difficile infection prevention bundle, can improve C. difficile infection rates. Although the exact impact of each component is not always clear, studies consistently report a reduction in infection rates when these bundles are implemented. ^{1 2 3 4 5}

What makes the Preemptive C. difficile infection prevention bundle treatment unique?

The Preemptive C. difficile infection prevention bundle is unique because it uses a comprehensive approach that includes multiple strategies like contact precautions, hand hygiene, and environmental cleaning to prevent infections before they occur, rather than treating them after they happen. This proactive method is different from standard treatments that typically focus on managing infections once they have developed. ^{1 2 6 7 8}

Research Team

Meghan A Baker, MD, SCD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of a C. difficile infection (CDI) reduction bundle and its components on CDI diagnosis and prevention. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Reducing C. difficile in children: An agent-based modeling approach to evaluate intervention effectiveness. [2021]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Institutional review of the implementation and use of a Clostridium difficile infection bundle and probiotics in adult trauma patients. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The potential value of Clostridium difficile vaccine: an economic computer simulation model. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Hospital Infection Control: Clostridioides difficile. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Prevention of hospital-onset Clostridium difficile infection in the New York metropolitan region using a collaborative intervention model. [2020]