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SepsisFAPIC-QENCT04103203

Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study

A study testing PathoRobot/ Patho-Doc Test result in people with Sepsis and Septic Shock, run by Hasselt University at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Septic Shock, Bacteremia
What is being tested?
PathoRobot/ Patho-Doc Test result
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,978 participants
Where
1 siteBelgium
Study dates
1 Jul 2019to 30 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Suspicion of sepsis
  • The drawning of blood cultures
  • Age >18 years

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Jessa Hospital

    Hasselt, Limburg, 3500

Other trials in Belgium

About this 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.

Being tested
PathoRobot/ Patho-Doc Test result
Medical subject headings
Sepsis, Shock, Septic, Bacteremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PathoRobot/ Patho-Doc Test resultDiagnostic test

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

Study groups in NCT04103203
Study groupRoleWhat they receive
New diagnostic results NOT availableNo interventionPatients 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.
New diagnostic results availableExperimentalPatients 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.
Receives: Diagnostic Test: PathoRobot/ Patho-Doc Test result

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: at study completion, 10 months

Secondary outcomes (9)

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

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

    Measured: at study completion, 10 months

  2. In-hospital mortality

    In-hospital mortality

    Measured: at study completion, 10 months

  3. Time to organism identification

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

    Measured: at study completion, 10 months

  4. Time to effective therapy

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

    Measured: at study completion, 10 months

  5. Time to optimal therapy

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

    Measured: at study completion, 10 months

  6. 30-day all cause mortality

    Number of patients with 30-day all cause mortality

    Measured: at study completion, 10 months

  7. Length-of-stay

    Length of hospital stay

    Measured: at study completion, 10 months

  8. Length of ICU stay

    Length of stay in an Intensive Care Unit

    Measured: at study completion, 10 months

  9. Destination at Discharge

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

    Measured: at study completion, 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start1 Jul 2019
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Quasi-experimental intervention
Masking
None (open label)
Enrolment
1,978 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04103203
Sponsor's protocol ID
19.51/Infect.19.02
Acronym
FAPIC-QE
Status last verified
Oct 2020
First submitted
12 Jul 2019
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PubMed 26903338

  • Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289.

    PubMed 26903336

  • Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

    PubMed 28101605

Questions about this trial

What is this clinical trial studying?

A study testing PathoRobot/ Patho-Doc Test result in people with Sepsis and Septic Shock, run by Hasselt University at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median time from specimen collection/arrival in the laboratory until antibiotic regimen change (time frame: at study completion, 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04103203, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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