FAPIC-QE: Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study

Sponsor
Hasselt University (Other)
Overall Status
Completed
CT.gov ID
NCT04103203
Collaborator
Jessa Hospital (Other), School of Medicine, University of Zagreb (Other), Molzym (Other), AIT Austrian Institute of Technology GmbH (Other), BEE Robotics (Other), University of Warwick (Other), Claude Bernard University (Other), Axo Science (Other)
1,978
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198

Study Details

Study Description

Brief Summary

The performance and clinical impact of two diagnostic systems will be evaluated using whole blood samples that are collected in parallel with samples for blood culture. As the rapid diagnostic systems will have the largest impact on severely ill patients (in need of a fast diagnosis) with bacterial infection, the evaluation will be performed in patients suspected of bacteraemia. During the study the new systems will be used in parallel with routine blood cultures. In alternating periods of 1 month, the results of the diagnostic system will be communicated to treating physicians (intervention) or not revealed (control). Blood culture results will be reported throughout the complete study period. Patients with suspected sepsis at the Emergency Department (ED), the department of infectious diseases/nephrology, and the department of haemodialysis will be included. In routine care, two blood culture sets (2x2 bottles) per patient are collected. One extra blood sample (EDTA tube, 9 ml of blood) will be sampled for each routine set of blood cultures. In addition, the clinical data of the patients will be collected. The samples will be sent to the clinical laboratory where samples are tested with the new systems during regular working hours in batches of 8 samples per run (2-3 runs per day). On average, 10%-20% of the blood cultures drawn on the presumption of bacteraemia yield bacterial pathogens. Previous data show that 13% of patients yield positive blood cultures. Thus, in order to collect blood samples of 100 new episodes of bacteraemia approximately 1000 patients (2000 blood cultures + 1000 EDTA tubes) have to be collected for each system (2000 patients in total). The results of the systems will be used to evaluate the clinical utility of the system regarding time to antibiotic treatment change and bacteraemia management. The system will be used directly for the diagnosis of patients, resulting in a possible change of treatment strategy. However, routine blood culture practices will still be done during the whole study period.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PathoRobot/ Patho-Doc Test result
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1978 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Quasi-experimental interventionQuasi-experimental intervention
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study
Actual Study Start Date :
Jul 1, 2019
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: New diagnostic results NOT available

Patients with suspected sepsis are included. Blood samples will be collected and analysed with the new diagnostics. However, results will not be communicated. Only the results of routine blood cultures will be availabtle to the treating physician. No intervention will take place, care is provided according to normal routine practices.

Experimental: New diagnostic results available

Patients with suspected sepsis are included. Blood samples will be collected and analysed with the new diagnostics. Results will be communicated via telephone by the consultant microbiologist and the electronic medical file to the treating physician. Results of routine blood cultures will also be available for all patients. Results of the new diagnostics are expected earlier, and the treating physician is able to make an earlier decision in terms of antibiotic therapy if he/she deems it necessary.

Diagnostic Test: PathoRobot/ Patho-Doc Test result
Test results of the new diagnostics will be available to the treating physician.

Outcome Measures

Primary Outcome Measures

  1. Median time from specimen collection/arrival in the laboratory until antibiotic regimen change [at study completion, 10 months]

    Time period between collection of blood cultures until the first change in antibiotic regimen

Secondary Outcome Measures

  1. Median time to appropriate, species-specific antibiotic therapy [at study completion, 10 months]

    Time period between collection of blood cultures until the first administration of species-specific antibiotic therapy

  2. In-hospital mortality [at study completion, 10 months]

    In-hospital mortality

  3. Time to organism identification [at study completion, 10 months]

    Time period between collection of blood cultures until the time to identification of a causative organism with the new diagnostics and with blood cultures

  4. Time to effective therapy [at study completion, 10 months]

    Time period between collection of blood cultures until the first administration of antibiotic therapy effective againts the causative organism

  5. Time to optimal therapy [at study completion, 10 months]

    Time period between collection of blood cultures until the first administration of antibiotic therapy that is optimal for patient recovery

  6. 30-day all cause mortality [at study completion, 10 months]

    Number of patients with 30-day all cause mortality

  7. Length-of-stay [at study completion, 10 months]

    Length of hospital stay

  8. Length of ICU stay [at study completion, 10 months]

    Length of stay in an Intensive Care Unit

  9. Destination at Discharge [at study completion, 10 months]

    Destination after discharge (home, rehabilitation home, nursing home, ...)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Suspicion of sepsis

  • The drawning of blood cultures

  • Age >18 years

Exclusion Criteria:
  • Children (<18 years)

  • Patients who are not hospitalized and sent home after ED admission

  • Duplicate blood cultures from the same bacteraemia episode (7days between positives with the same organism, or 24h for different organisms)

  • Patients from who blood cultures are drawn on Friday evening (17h) or Saturday during intervention periods

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jessa Hospital Hasselt Limburg Belgium 3500

Sponsors and Collaborators

  • Hasselt University
  • Jessa Hospital
  • School of Medicine, University of Zagreb
  • Molzym
  • AIT Austrian Institute of Technology GmbH
  • BEE Robotics
  • University of Warwick
  • Claude Bernard University
  • Axo Science

Investigators

  • Principal Investigator: Inge C Gyssens, MD, PhD, Hasselt University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
prof. dr. Inge Gyssens, Prof. dr., Hasselt University
ClinicalTrials.gov Identifier:
NCT04103203
Other Study ID Numbers:
  • 19.51/Infect.19.02
First Posted:
Sep 25, 2019
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2020