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

Phase 4

Withdrawn

• Conditions: Bacteremia
• Interventions: Drug: Continuous infusion of beta-lactam antibiotics .; Other: Therapeutic drug monitoring of beta-lactam antibiotics.

• Registration Number: NCT03108690
• Lead Sponsor: Sara Thønnings

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 Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Study Start: 2017-10-01
• Status Verified: 2023-03
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
TDM and CI.	Therapeutic drug monitoring of beta-lactam antibiotics.	Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.
TDM and CI.	Continuous infusion of beta-lactam antibiotics .	Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.

Primary Outcome Measures

Name	Time	Method
Target concentrations.	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 Outcome Measures

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