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C Difficile Near-patient Diagnostics

NCT03857464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3816

Last updated 2023-05-09

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Near Patient Testing

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.

DIAGNOSTIC_TEST

SOP for C. difficile diagnostics

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Alberta Health services

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Dyan Pillai, MD, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857464 on ClinicalTrials.gov