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Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia

Primary Purpose

Bacteremia

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Continuous infusion of beta-lactam antibiotics .
Therapeutic drug monitoring of beta-lactam antibiotics.
Sponsored by
Sara Thønnings
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacteremia focused on measuring Therapeutic drug monitoring, Continuous infusion, Beta-lactam, Antibiotics, Bacteraemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a positive blood culture.
  • Undergo treatment with either intravenous penicillin, ampicillin, piperacillin/tazobactam, dicloxacillin, cefuroxime or meropenem.
  • Hospitalised at Hvidovre University Hospital.
  • Age ≥ 18.
  • Able to understand and give informed consent.
  • Included in the study within 24 hours after the final positive blood culture answer.

Exclusion Criteria:

  • Positive blood culture is interpreted as contamination.
  • The patient dies before the intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    TDM and CI.

    Control

    Arm Description

    Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.

    Beta-lactam antibiotics given as intermittent infusion. Samples of serum concentration of beta-lactam will be collected for comparison, but blinded during the study.

    Outcomes

    Primary Outcome Measures

    Target concentrations.
    Serum concentrations within the target values for intervention. Following beta-lactams is included in the study: Benzylpenicillin, ampicillin, dicloxacillin, piperacillin/tazobactam, cefuroxime and meropenem.

    Secondary Outcome Measures

    Morbidity.
    Diagnoses compared between the two arms.
    Number of days until medically discharged.
    Number of days until medically discharged compared between the two arms.
    Failed antibiotic treatments.
    Adding an additional antibiotic and/or change to a different antibiotic (not including a more narrow spectrum antibiotic) compared between the two arms.
    Amount of antibiotic used.
    Defined daly doses of antibiotic therapy compared between the two arms.
    Antibiotic side effects and complications.
    The severity of bacteraemia, mechanical ventilation and start-up of dialysis compared between the two arms. Growth of antibiotic-associated pathogenic in patient material compared between the two arms.
    Mortality.
    30-day mortality compared between the two arms.
    Number of participants with abnormal clinical data and/or abnormal laboratory values.
    Clinical data includes height, weight, heart rate, blood pressure, respiratory rate, Glasgow Coma Scale score, body temperature, fous of infection, the severity of bacteraemia, dialysis and laboratory values includes hemoglobin, white blood cells, neutrophils, thrombocytes, C-reactive protein, sodium, potassium, creatinine, albumin, lactate dehydrogenase, alanine amino transferase and lactate. Both will be compared between the two arms.

    Full Information

    First Posted
    March 30, 2017
    Last Updated
    March 27, 2023
    Sponsor
    Sara Thønnings
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03108690
    Brief Title
    Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia
    Official Title
    Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Logistics
    Study Start Date
    October 1, 2017 (Anticipated)
    Primary Completion Date
    March 9, 2023 (Actual)
    Study Completion Date
    March 9, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Sara Thønnings

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacteremia
    Keywords
    Therapeutic drug monitoring, Continuous infusion, Beta-lactam, Antibiotics, Bacteraemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TDM and CI.
    Arm Type
    Experimental
    Arm Description
    Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Beta-lactam antibiotics given as intermittent infusion. Samples of serum concentration of beta-lactam will be collected for comparison, but blinded during the study.
    Intervention Type
    Drug
    Intervention Name(s)
    Continuous infusion of beta-lactam antibiotics .
    Other Intervention Name(s)
    Benzylpenicillin, Ampicillin, Dicloxacillin, Piperacillin/tazobactam, Cefuroxime, Meropenem
    Intervention Description
    Beta-lactam antibiotic will be administered as continous infusion.
    Intervention Type
    Other
    Intervention Name(s)
    Therapeutic drug monitoring of beta-lactam antibiotics.
    Intervention Description
    Dosage of beta-lactam antibiotics will be adjusted according to serum concentration.
    Primary Outcome Measure Information:
    Title
    Target concentrations.
    Description
    Serum concentrations within the target values for intervention. Following beta-lactams is included in the study: Benzylpenicillin, ampicillin, dicloxacillin, piperacillin/tazobactam, cefuroxime and meropenem.
    Time Frame
    30 days after intervention.
    Secondary Outcome Measure Information:
    Title
    Morbidity.
    Description
    Diagnoses compared between the two arms.
    Time Frame
    30 days after intervention.
    Title
    Number of days until medically discharged.
    Description
    Number of days until medically discharged compared between the two arms.
    Time Frame
    30 days after intervention.
    Title
    Failed antibiotic treatments.
    Description
    Adding an additional antibiotic and/or change to a different antibiotic (not including a more narrow spectrum antibiotic) compared between the two arms.
    Time Frame
    30 days after intervention.
    Title
    Amount of antibiotic used.
    Description
    Defined daly doses of antibiotic therapy compared between the two arms.
    Time Frame
    30 days after intervention.
    Title
    Antibiotic side effects and complications.
    Description
    The severity of bacteraemia, mechanical ventilation and start-up of dialysis compared between the two arms. Growth of antibiotic-associated pathogenic in patient material compared between the two arms.
    Time Frame
    30 days after intervention.
    Title
    Mortality.
    Description
    30-day mortality compared between the two arms.
    Time Frame
    30 days after intervention.
    Title
    Number of participants with abnormal clinical data and/or abnormal laboratory values.
    Description
    Clinical data includes height, weight, heart rate, blood pressure, respiratory rate, Glasgow Coma Scale score, body temperature, fous of infection, the severity of bacteraemia, dialysis and laboratory values includes hemoglobin, white blood cells, neutrophils, thrombocytes, C-reactive protein, sodium, potassium, creatinine, albumin, lactate dehydrogenase, alanine amino transferase and lactate. Both will be compared between the two arms.
    Time Frame
    30 days after intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have a positive blood culture. Undergo treatment with either intravenous penicillin, ampicillin, piperacillin/tazobactam, dicloxacillin, cefuroxime or meropenem. Hospitalised at Hvidovre University Hospital. Age ≥ 18. Able to understand and give informed consent. Included in the study within 24 hours after the final positive blood culture answer. Exclusion Criteria: Positive blood culture is interpreted as contamination. The patient dies before the intervention.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sara Thønnings, MD
    Organizational Affiliation
    Hvidovre University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia

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