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

NCT ID: NCT03108690

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2023-03-09

Brief Summary

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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

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Conditions

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Bacteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TDM and CI.

Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.

Group Type EXPERIMENTAL

Continuous infusion of beta-lactam antibiotics .

Intervention Type DRUG

Beta-lactam antibiotic will be administered as continous infusion.

Therapeutic drug monitoring of beta-lactam antibiotics.

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Continuous infusion of beta-lactam antibiotics .

Beta-lactam antibiotic will be administered as continous infusion.

Intervention Type DRUG

Therapeutic drug monitoring of beta-lactam antibiotics.

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

Intervention Type OTHER

Other Intervention Names

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Benzylpenicillin Ampicillin Dicloxacillin Piperacillin/tazobactam Cefuroxime Meropenem

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sara Thønnings

OTHER

Sponsor Role lead

Responsible Party

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Sara Thønnings

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sara Thønnings, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Other Identifiers

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2015-768

Identifier Type: -

Identifier Source: org_study_id

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