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Completed

NCT Number: NCT04103203

Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study

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.

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Key information

Conditions

Sepsis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PathoRobot/ Patho-Doc Test result

Diagnostic Test

Test results of the new diagnostics will be available to the treating physician.

Primary outcomes

  1. Median time from specimen collection/arrival in the laboratory until antibiotic regimen change

    Time frame: at study completion, 10 months

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

Secondary outcomes

  1. Median time to appropriate, species-specific antibiotic therapy

    Time frame: 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

    Time frame: at study completion, 10 months

    In-hospital mortality

  3. Time to organism identification

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: at study completion, 10 months

    Number of patients with 30-day all cause mortality

  7. Length-of-stay

    Time frame: at study completion, 10 months

    Length of hospital stay

  8. Length of ICU stay

    Time frame: at study completion, 10 months

    Length of stay in an Intensive Care Unit

  9. Destination at Discharge

    Time frame: at study completion, 10 months

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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

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

Registry information

Acronym: FAPIC-QE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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