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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03108690

Enrollment

Registered

2017-04-11

Start date

2017-10-01

Completion date

2023-03-09

Last updated

2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia

Keywords

Therapeutic drug monitoring, Continuous infusion, Beta-lactam, Antibiotics, 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.

Interventions

DRUGContinuous infusion of beta-lactam antibiotics .

Beta-lactam antibiotic will be administered as continous infusion.

OTHERTherapeutic drug monitoring of beta-lactam antibiotics.

Dosage of beta-lactam antibiotics will be adjusted according to serum concentration.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Number of days until medically discharged.	30 days after intervention.	Number of days until medically discharged 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.
Morbidity.	30 days after intervention.	Diagnoses 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.
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026