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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Sara Thønnings

Current Primary Outcome: 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, cefuroxim and meropenem.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 narrowspectrum antibioitic) 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.


Original Secondary Outcome: Same as current

Information By: Hvidovre University Hospital

Dates:
Date Received: March 30, 2017
Date Started: May 2017
Date Completion: August 2018
Last Updated: April 5, 2017
Last Verified: April 2017