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.

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.

Clostridium Difficile

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.

Near Patient Testing

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

SOP for C. difficile diagnostics

Calgary Laboratory Services

Foothills Medical Center Rapid Response Laboratory

C Difficile Near-patient Diagnostics

C. Difficile Near-patient Testing Versus Centralized Laboratory Testing: a Cluster Randomized Trial

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

Turn-around times from specimen submission to result back to the clinical staff

Days as inpatient in hospital for a given patient during a hospital stay

The number of days of antibiotic therapy for a given patient during a hospital stay

Severity of Clostridium difficile infection as defined in study design per patient

Number of patients that experience mortality

The cost of tests, patient isolation cost, laboratory staff costs, and other hospitalization costs for patients in the control and treatment arms.

Dylan Pillai

Professor Departments of Pathology & Laboratory Medicine, Medicine, and Microbiology & Infectious Diseases, University of Calgary, Diagnostic & Scientific Centre,

University of Calgary

Canadian Institutes of Health Research (CIHR)

Alberta Health Services

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.

Not possible as integrating diagnostic into hospital system.

Fidaxomicin with alternating matching placebo

Participants received 4 doses (1 dose every 6 hours) of oral vancomycin hydrochloride each day for the duration of the 10-day treatment period

Fidaxomicin

Vancomycin

Placebo

Link to results on Astellas Clinical Study Results website

Univ. Klinik für Innere Medizi

Herlev University Hospital

Institut Curie

Hôpital Necker

Charité

Universitätsklinikum

Universitätsklinikum Halle

Klinik I für Innere Medizin

General Hospital of Athens

Laiko General Hospital

University Hospital of Crete

Metaxa Anticancer Hospital

Szpital Specjalistyczny w Brzo

H. U. de Bellvitge

H.U. Gregorio Maranon

Hospital 12 de Octubre

A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System

A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy

Clinical cure is defined as a subject that at TOC no further CDI therapy is required since completion of study medication, and has either:
≤3 unformed bowel movements for two consecutive days
≥50% reduction in the number of unformed bowel movements compared to baseline; or
75% reduction in the volume of liquid stool collected or no longer passing liquid stools (for subjects having rectal collection device)

Total viable count of clostridium difficile recovered from fecal specimen is below the limit of detection

First of two days with <3 bowel movements per day

After TOC, re-establishment of diarrhea to an extent that is greater than the frequency recorded on the last day of study medication

Time elapsing (days) from TOC to confirmed recurrence of CDI

Astellas Pharma Europe Ltd.

Cubist Pharmaceuticals LLC

Patients will be treated with an antibiotic as soon as the aspirate obtained at the colonoscopy is found to be positive for C. diff.

Treatment will be started after a delay after the aspirate obtained at the colonoscopy is found to be C. diff positive.

glutamate dehydrogenase/diarrhea

C Difficile Near-patient Diagnostics

A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System

Prospective Study of Clostridium Difficile in Children Undergoing Colonoscopy

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