Clinical trial NCT02968758: Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
Official title: Prospective Multi-Center Study for Clinical Validation of the Molecular-Based GenePOC CDiff System for the Detection of Toxin B Gene From Toxigenic Clostridium Difficile Strains in Unformed (Soft or Liquid) Human Stool Specimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clostridium Difficile Infection
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 2461
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method considered as gold standard for detection of toxigenic Clostridium difficile in stool specimens.

Detailed description: The GenePOC CDiff test performed on the GenePOC™ instrument is a qualitative in vitro diagnostic (IVD) test that utilizes automated sample preparation and real-time polymerase chain reaction (rtPCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI).

The GenePOC CDiff system comprises the GenePOC instrument and the GenePOC CDiff test, which consists of:

1. Transfer Loop (TL)
2. CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)
3. CDiff Sample Buffer Tube (SBT)
4. Disposable Transfer Tool (DTT).

The GenePOC Instrument is fully automated and integrates sample lysis, dilution, amplification and detection of the target sequence in complex samples using real-time Polymerase chain reaction (rtPCR). User intervention is only required for discharging the patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly interface, two barcode readers, and integrated firmware and software to deliver results to the user. The PIE is a closed system that prevents the risk of contamination.

An unformed (soft or liquid) stool specimen is collected using standard stool collection device. Using a disposable 5µL inoculating loop (transfer loop) dipped into the homogenized stool specimen, stool material is transferred into SBT and vortexed. Sample is then transferred to the GenePOC CDiff PIE. The GenePOC CDiff PIE is then automatically processed by the GenePOC Instrument. On completion of a run, the user removes the processed PIEs from the instrument and discards them according to local biological waste management procedures.

One GenePOC instrument per site will be allocated. The purpose of the clinical investigation is to enroll sufficient specimens from up to 7 Clinical Centers to obtain a total of 150 specimens positive for CDiff based on the Reference Method final result.

Subject Informed consent is not required for this clinical trial as the testing will be performed on excess de-identified specimens only.

Eligibility criteria: Inclusion Criteria:

* Unformed Stool specimens from patients suspected of having CDI for whom diagnostic tests are indicated and ordered;
* At least 1.25mL of unformed stool specimen (defined as specimen assuming the shape of its container);
* Only one (1) specimen per patient will be included in the study;
* Materials use within their expiration date;
* Transport, storage times, and conditions (e.g. room temperature and/or refrigerated) within requested indications.

Exclusion Criteria:

* Specimens from patients for whom CDI diagnostic tests have not been ordered;
* Transport and storage times and conditions that exceed these Study Protocol requirements;
* Formed or hard stool specimens or rectal swabs.

Primary outcomes:
measure: Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method
timeFrame: At the time of the results with Reference Method is confirmed, up to 3 months
Secondary outcomes:
measure: Positive and Negative Predictive Values (PPV and NPV)
timeFrame: At the time of the results with Reference Method is confirmed, up to 3 months
measure: Unresolved Sample Results
timeFrame: At the time of the results with Reference Method is confirmed, up to 3 months
measure: Indeterminate Sample Results
timeFrame: At the time of the results with Reference Method is confirmed, up to 3 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Wishard Health Services
state: Indiana
city: Baltimore
country: United States
facility: John Hopkins University School of Medicine
state: Maryland
city: Detroit
country: United States
facility: Detroit Medical Center University Laboratories
state: Michigan
city: Albuquerque
country: United States
facility: Tricore Laboratory University of New Mexico
state: New Mexico
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Meridian Bioscience, Inc.
name: Patrice Allibert
role: STUDY_DIRECTOR
References: