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Procalcitonin to Guide Antibiotic Stop in Neurocritical Care Patients.

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ClinicalTrials.gov Identifier: NCT03683693
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Stoffel Lamote, General Hospital Groeninge

Brief Summary:

Antibiotic overconsumption has been considered as one of the major contributive factors of the emergence of multidrug resistant bacteria, a serious threat particularly in intensive care units. Antibiotic stewardship programs are set up to meet this problem. Shortening the duration of antimicrobial therapy seems to be one of the strongest tools of these programs. Nevertheless, the decision to stop antibiotics in a critical care patients remains often challenging in real-life practice.

Procalcitonin (PCT), an inflammatory biomarker, has a promising profile and scores better than traditionally biomarkers as c-reactive protein (crp) and leucocytosis. Although two big multicenter randomised controlled trials showed a positive impact of PCT use in Intensive Care Unit (ICU), as it led to reduction of antibiotic exposure, the efficiency of this biomarker is still a point of debate. Notably the cost of PCT determination is a counterargument for its routinely use as it is a quite expensive test and its cost-benefit ratio has not been well studied.

The objective of this study is to test a PCT-algorithm for stopping antibiotics in a real life setting by assessing its impact on antibiotic consumption. The investigators hypothesize that it will shorten antimicrobial courses and will decrease overconsumption, with a possible positive impact on the increase of antimicrobial resistance and with no apparent adverse outcome.


Condition or disease Intervention/treatment Phase
Sepsis Diagnostic Test: Procalcitonin group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Matched cohort: historical standard of care group (patients from the period January 2016 - April 2018) versus interventional group (patients from May 2018 on)
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Procalcitonin to Guide Antibiotic Stop in Neurocritical Care Patients. An Interventional Matched-cohort Study.
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
No Intervention: Standard of Care group
Historical Group = Standard of Care group. Decision for stopping antibiotics taken by ICU physician: assessment on the basis of the clinical picture and traditional inflammatory biomarkers such as crp and leucocytosis
Experimental: Procalcitonin group
ICU physician gets on regular base PCT value, what can be used as additive tool in the decision-making for stopping antibiotics.
Diagnostic Test: Procalcitonin group

The ICU physician gets on regular base (day 0, d4, d7, d11, d15, d19, d23, d27) a PCT value and the according non-binding recommendation:

PCT < 0.5 microgram/L of 80% drop of the peak value : antibiotic stop recommended.

PCT < 0.25 microgram/L: antibiotic stop strongly recommended. The recommendation is not-binding and can be overruled by the ICU physician. The intervention is only set up for stopping antibiotics, not for initiating. PCT measurements only happens in case of still ongoing antibiotic course. In case of a second course of antibiotics, after interruption of the initial course, new PCT measurement will take place at this point followed by the continuation of the initial schedule of PCT measurement.

Intervention ends 28 days after inclusion.





Primary Outcome Measures :
  1. Antibiotic use [ Time Frame: at day 28 ]
    We will measure the duration of the first uninterrupted antibiotic course, expressed as Days of Therapy (DOT) and as Defined Defined Daily Doses (DDD) and the Antibiotic consumption during first 28 days expressed as antibiotic free days (alive) within the first 28 days after inclusion.


Secondary Outcome Measures :
  1. ICU and mortality [ Time Frame: up to 6 months after inclusion ]
    We will measure ICU mortality from all causes and infection related ICU mortality by recording date of death

  2. 28-days mortality (from all causes) [ Time Frame: at day 28 ]
    We will measure 28-days mortality from all causes and infection related 28-days mortality by recording date of death

  3. Hospital mortality [ Time Frame: up to 6 months after inclusion ]
    date of death

  4. ICU and hospital length of stay [ Time Frame: up to 6 months after inclusion ]
    numbers of days in ICU and in hospital respectively

  5. Duration of Mechanical ventilation [ Time Frame: at day 28 ]
    numbers of days alive without ventilatory support (defined as unassisted breathing) during intervention period

  6. Recurrent infection [ Time Frame: at day 28 ]
    Number of patients with relapse or superinfection during ICU stay (patients requiring a new course of antibiotic therapy after a former fully completed course)

  7. Reinfection [ Time Frame: at day 28 ]
    Number of patients with microbiologically proven reinfection with the same pathogen in ICU

  8. Multidrug Resistance [ Time Frame: up to 3 months after inclusion ]
    Incidence of new multidrug resistant bacteria, isolated from specimens taken for routine microbiological assessment during ICU stay

  9. Multidrug Resistance [ Time Frame: up to 6 months after inclusion ]
    Incidence of new multidrug resistant bacteria, isolated from specimens taken for routine microbiological assessment during hospitalisation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients admitted to the ICU with a primary non-infectious neurological pathology:

    • Traumatic Brain Injury
    • Intracerebral Bleeding (pe. subarachnoid bleeding) due to aneurysm or arteriovenous malformation
    • Ischemic Stroke Stroke
    • Hemorrhagic stroke or other intracranial haemorrhage
    • Other non-infectious neurologic condition (as hydrocephalus, status epilepticus, postoperative complication after elective neurosurgery, ...)

    AND

  2. requiring antibiotics within the first week (day 0 - day 6) after ICU-admission for a suspected bacterial infection

Exclusion Criteria:

  • severe immunodeficiency and/or neutropenia: defined as (1) solid-organ transplant recipients with immunosuppressive therapy (monotherapy with corticosteroids is allowed), (2) recent chemotherapy in last 6 months, (3) hematologic malignancy with active therapy in last 2 years, (4) bone marrow transplant, (5) HIV patient with clinical complications (Pneumocystis jirovecii, Kaposi's sarcoma, lymphoma, tuberculosis, toxoplasmosis, …) or CD4 count < 200/mm3, while neutropenia has been defined as white cell count < 1000/ml.
  • microbiologically proven infection with Pseudomonas, Acinetobacter baumannii, Lysteria or atypical pathogen as Chlamydia, Legionella or Mycoplasma; or Staphylococcal aureus bacteremia
  • microbiologically proven meningitis or ventriculitis
  • compartmentalised infection: pe. abscess, empyema
  • microbiologically proven (co-)infection making a prolonged antibiotic course necessary, such as endocarditis, prosthetic joint infection or septic arthritis, osteomyelitis, chronic prostatitis, ...
  • already > 24h on antibiotics before ICU admission
  • (expected) ICU length of stay < 7 days
  • no match available in the historical 'Standard of Care' group
  • no Informed Consent obtained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683693


Contacts
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Contact: Stoffel Lamote, MD 3256633055 stoffel.lamote@azgroeninge.be
Contact: Wouter De Corte, MD, PhD 3256633047 wouter.decorte@azgroeninge.be

Locations
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Belgium
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: Stoffel Lamote, MD         
Sponsors and Collaborators
General Hospital Groeninge
Investigators
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Principal Investigator: Stoffel Lamote, MD AZ Groeninge

Additional Information:
Publications:
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.

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Responsible Party: Stoffel Lamote, Stoffel Lamote, MD, General Hospital Groeninge
ClinicalTrials.gov Identifier: NCT03683693     History of Changes
Other Study ID Numbers: AZGS2017164
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stoffel Lamote, General Hospital Groeninge:
procalcitonin
antibiotic stewardship in ICU
Multidrug resistance
neurocritical care

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents