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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2018

Interventions

  • Drug: Continuous infusion of beta-lactam antibiotics .
    • Beta-lactam antibiotic will be administered as continous infusion.
  • Other: Therapeutic drug monitoring of beta-lactam antibiotics.
    • Dosage of beta-lactam antibiotics will be adjusted according to serum concentration.

Arms, Groups and Cohorts

  • Experimental: TDM and CI.
    • Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.
  • No Intervention: Control
    • Beta-lactam antibiotics given as intermittent infusion. Samples of serum concentration of beta-lactam will be collected for comparison, but blinded during the study.

Clinical Trial Outcome Measures

Primary Measures

  • Target concentrations.
    • Time Frame: 30 days after intervention.
    • 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 Measures

  • Morbidity.
    • Time Frame: 30 days after intervention.
    • Diagnoses compared between the two arms.
  • Number of days until medically discharged.
    • Time Frame: 30 days after intervention.
    • Number of days until medically discharged compared between the two arms.
  • Failed antibiotic treatments.
    • Time Frame: 30 days after intervention.
    • 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.
    • Time Frame: 30 days after intervention.
    • Defined daly doses of antibiotic therapy compared between the two arms.
  • Antibiotic side effects and complications.
    • Time Frame: 30 days after intervention.
    • 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.
    • Time Frame: 30 days after intervention.
    • 30-day mortality compared between the two arms.
  • Number of participants with abnormal clinical data and/or abnormal laboratory values.
    • Time Frame: 30 days after intervention.
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sara Thønnings
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Sara Thønnings, MD – Hvidovre University Hospital
  • Overall Official(s)
    • Sara Thønnings, MD, Principal Investigator, Hvidovre University Hospital
  • Overall Contact(s)
    • Sara Thønnings, MD, +45 38621783, sara.thoennings@regionh.dk

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.