Clostridium Difficile Infection Clinical Trial
Official title:
Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection
The objective is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control) with crossover at 12 months, following a 6-month washout period. Outcome measures include the rates of HAIs, as well as the recurrence of genetically identical clinical strains of HAIs among patients on study units. The study will be conducted in 2 hospitals covering 16 total hospital units at Detroit Medical Center. Our central hypothesis is that the addition of PX-UV to standard terminal cleaning will be associated with a significant reduction in the rate of HAIs, as well as a reduction in the recovery of genetically identical strains of MDROs. The impact of PX-UV disinfection on rates of HAIs on study units will be determined by comparing rates of HAIs on a) study units where PX-UV is added to standard terminal cleaning practices to b) units where a sham UV disinfection system is added to standard terminal cleaning; and by comparing rates of HAIs on the same medical ward during each of two 12-month phases of a crossover study (one phase when a PX-UV device is added and one when a sham device is added to standard terminal cleaning). The long-term goal of this project is to establish the efficacy of terminal cleaning plus PX-UV in reducing rates of HAIs due to the following multi-drug resistant organisms (MDROs): C. difficile, vancomycin-resistant enterococci (VRE), Klebsiella pneumoniae and Escherichia coli producing extended-spectrum beta-lactamases (ESBLs), methicillin-resistant Staphylococcus aureus (MRSA) and Acinetobacter baumannii. At the conclusion of the proposed project, novel data will be generated from this rigorously controlled study regarding the effectiveness of PX-UV in reducing HAIs in a representative, real-world healthcare setting.
In 2011, 721,800 healthcare-associated infections (HAIs) were reported in the United States. The hospital environment has been increasingly recognized as an important determinant of HAI acquisition and prevention of HAIs has become a top priority for the U.S. Department of Health and Human Services (HHS). Terminal cleaning of a patient room is recognized as a critically important process to help prevent HAIs and involves extensive cleaning and disinfection of the room after a patient has been discharged from the room and before the subsequent patient has been admitted to the room. Pulsed xenon ultraviolet light (PX-UV) has been shown to be effective in killing a variety of pathogens including endospores of Clostridium difficile. PX-UV works quickly - the entire cycle time for use in a hospital room is 15 minutes. To date, the clinical impact of adding PX-UV to terminal cleaning has not been demonstrated in clinical trials with sham controls or in a crossover design. The long-term goal of this project is to establish the efficacy of terminal cleaning plus PX-UV in reducing rates of HAIs due to the following multi-drug resistant organisms (MDROs): C. difficile, vancomycin-resistant enterococci (VRE), Klebsiella pneumoniae and Escherichia coli producing extended-spectrum beta-lactamases (ESBLs), methicillin-resistant Staphylococcus aureus (MRSA) and Acinetobacter baumannii. The objective of this application is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control) with crossover at 12 months, following a 6-month washout period. Outcome measures include the rates of HAIs, as well as the recurrence of genetically identical clinical strains of HAIs among patients on study units. The study will be conducted in 2 hospitals covering 16 total hospital units at Detroit Medical Center. Our central hypothesis is that the addition of PX-UV to standard terminal cleaning will be associated with a significant reduction in the rate of HAIs, as well as a reduction in the recovery of genetically identical strains of MDROs. The impact of PX-UV disinfection on rates of HAIs on study units will be determined by comparing rates of HAIs on a) study units where PX-UV is added to standard terminal cleaning practices to b) units where a sham UV disinfection system is added to standard terminal cleaning; and by comparing rates of HAIs on the same medical ward during each of two 12-month phases of a crossover study (one phase when a PX-UV device is added and one when a sham device is added to standard terminal cleaning). At the conclusion of the proposed project, novel data will be generated from this rigorously controlled study regarding the effectiveness of PX-UV in reducing HAIs in a representative, real-world healthcare setting. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02214771 -
Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients
|
N/A | |
Withdrawn |
NCT01552668 -
Fidaxomicin to Prevent Clostridium Difficile Colonization
|
Phase 4 | |
Recruiting |
NCT03325855 -
Fecal Microbiota Transplant National Registry
|
||
Not yet recruiting |
NCT03586206 -
Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
|
||
Suspended |
NCT03350711 -
A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program
|
||
Withdrawn |
NCT03643887 -
Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients
|
Phase 2 | |
Terminated |
NCT04000555 -
Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)
|
Phase 4 | |
Terminated |
NCT03065374 -
Treatment for Clostridium-difficile Infection With IMM529
|
Phase 1/Phase 2 | |
Completed |
NCT03710694 -
Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)
|
N/A | |
Completed |
NCT02865616 -
MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI)
|
Phase 1 | |
Recruiting |
NCT04940468 -
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology
|
N/A | |
Completed |
NCT02589847 -
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
|
Phase 2 | |
Not yet recruiting |
NCT01942447 -
Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis
|
N/A | |
Active, not recruiting |
NCT02086916 -
Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection
|
N/A | |
Completed |
NCT01230957 -
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
|
Phase 2 | |
Completed |
NCT01241552 -
A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
|
Phase 3 | |
Not yet recruiting |
NCT04567134 -
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
|
||
Completed |
NCT04075422 -
Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
|
||
Recruiting |
NCT03712722 -
Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
|
||
Recruiting |
NCT05192148 -
Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile
|
N/A |