Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Target concentrations.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
TDM and CI.
Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.
Intervention: Continuous infusion of beta-lactam antibiotics . (Drug)
TDM and CI.
Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.
Intervention: Therapeutic drug monitoring of beta-lactam antibiotics. (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Morbidity.(30 days after intervention.)
- Number of days until medically discharged.(30 days after intervention.)
- Failed antibiotic treatments.(30 days after intervention.)
- Amount of antibiotic used.(30 days after intervention.)
- Antibiotic side effects and complications.(30 days after intervention.)
- Mortality.(30 days after intervention.)
- Number of participants with abnormal clinical data and/or abnormal laboratory values.(30 days after intervention.)
Investigators
Sara Thønnings
MD
Hvidovre University Hospital