C Difficile Near-patient Diagnostics

NCT03857464 | Completed

• 1 other identifier: REB 18 0397
• Study Type: interventional
• Target: 3,816
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators will conduct a two-period, two-intervention, cluster randomized crossover (CRXO) designed study at Foothills Hospital in Calgary, Alberta. Each cluster (hospital ward) will receive each of the two interventions in a separate approximately 6-month period of time leading to two "cluster-periods" with associated "wash-in" and "wash-out" periods attached. The two interventions are: 1) a rapid diagnostic test (RDT) using near-patient testing (NPT) for C. difficile infections (CDI); 2) testing for CDI using centralized testing facilities (standard operating procedure, 2 step algorithm). The investigators hypothesize that NPT for CDI will result in reduced patient isolation days in the hospital, decreased morbidity and mortality, reduced unnecessary antibiotic use and overall reduced costs to the health care system, including both hospital and laboratory. Our primary endpoint is to examine the differential effect of NPT on the duration of contact precautions (i.e. patient isolation days). Secondary outcomes will compare turn-around times from specimen submission to result, days of hospitalization, the number of days of antibiotic therapy, the incidence of CDI, severe CDI, and in-hospital mortality. A comprehensive economic evaluation will be performed to determine the cost of testing, patient isolation, and hospitalization for all patients in the control and treatment arms.

Conditions

Clostridium Difficile

Keywords

Near-Patient Testing; Clostridioides difficile; nosocomial infections; Clostridium difficile Infection

Outcome Measures

Primary Outcomes (1)

• Duration of contact precautions during hospital stay

  Differential effect of near patient testing on the duration of contact precautions (i.e. patient isolation days) with hospital-acquired CDI

  Through study completion, an average of 1 year: measured during a given hospital stay for a patient

Secondary Outcomes (7)

• Test turn around

  Through study completion, an average of 1 year

• Hospitalization Days Per Patient

  Through study completion, an average of 1 year

• Length of antibiotic therapy

  Through study completion, an average of 1 year

• Incidence of Clostridium difficile infections

  Through study completion, an average of 1 year

• Severity of Clostridium difficile infection

  Through study completion, an average of 1 year

Study Arms (2)

Crossover Arm One

OTHER

Hospital wards in this arm will use C. DIFF QUIK CHEK COMPLETE® for near-patient testing for the first phase of the crossover. For the second phase of the crossover, Arm One will utilize standard operating procedure testing for C. difficile infections using the centralized testing facilities.

Diagnostic Test: Near Patient Testing; Diagnostic Test: SOP for C. difficile diagnostics

Crossover Arm Two

OTHER

Hospital wards in this arm will utilize testing for C. difficile infections using the centralized testing facilities in phase 1 and will switch to using C. DIFF QUIK CHEK COMPLETE® for near-patient testing in phase 2 of the crossover design.

Diagnostic Test: Near Patient Testing; Diagnostic Test: SOP for C. difficile diagnostics

Interventions

Near Patient Testing DIAGNOSTIC_TEST

Near-patient testing will be conducted at Foothills Hospital rapid response lab. Negative results using C. DIFF QUIK CHEK COMPLETE® will be reported immediately to the patient wards. Positive results will be confirmed using nucleic acid testing at the centralized testing facility.

Crossover Arm One; Crossover Arm Two

SOP for C. difficile diagnostics DIAGNOSTIC_TEST

Two-step testing algorithm for Clostridium difficile at centralized testing facilities. No change from the current protocol.

Crossover Arm One; Crossover Arm Two

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients located on inpatient wards for whom C. difficile test is ordered at Foothills Medical Center. Usually defined by having 3 or more loose bowel movements in a 24 hour period.

You may not qualify if:

• No diagnostics for C. difficile requested. Inpatient at a different facility. All outpatients.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Health services: collaborator

Study Sites (2)

Calgary Laboratory Services

Calgary, Alberta, T2L 2K8, Canada

Location

Foothills Medical Center Rapid Response Laboratory

Calgary, Alberta, T2L 2K8, Canada

Location

Related Publications (1)

• Doolan CP, Sahragard B, Leal J, Sharma A, Kim J, Spackman E, Hollis A, Pillai DR. Clostridioides difficile Near-Patient Testing Versus Centralized Testing: A Pragmatic Cluster Randomized Crossover Trial. Clin Infect Dis. 2023 Jun 8;76(11):1911-1918. doi: 10.1093/cid/ciad046.

  PMID: 36718646 DERIVED

MeSH Terms

Conditions

Cross Infection; Clostridium Infections

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Dyan Pillai, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not possible as integrating diagnostics into the hospital system.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Departments of Pathology & Laboratory Medicine, Medicine, and Microbiology & Infectious Diseases, University of Calgary, Diagnostic & Scientific Centre,

Model Details: Study design is a two-period, two-intervention, cluster randomized crossover (CRXO) design, in which each cluster (ward) receives each of the two interventions in a separate 6-month period of time leading to two "cluster-periods". The order in which the interventions are delivered to each cluster (ward) is randomized to control for potential period effects. Within Foothills Hospital there are 40 wards which will be observed over a 12-month period. Each ward is randomly assigned to administer one of the two interventions for the first 6-month period (Period 1). In the second 6-month period (Period 2), the ward will administer the other intervention. Within each ward (cluster) there are two cluster-periods.

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: February 28, 2019
• Study Start: January 15, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)