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Clinical Trials/NCT03108690
NCT03108690
Withdrawn
Phase 4

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

Sara Thønnings0 sitesOctober 1, 2017

Overview

Phase
Phase 4
Intervention
Continuous infusion of beta-lactam antibiotics .
Conditions
Bacteremia
Sponsor
Sara Thønnings
Primary Endpoint
Target concentrations.
Status
Withdrawn
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
March 9, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Sara Thønnings
Responsible Party
Sponsor Investigator
Principal Investigator

Sara Thønnings

MD

Hvidovre University Hospital

Eligibility Criteria

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 .

TDM and CI.

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

Intervention: Therapeutic drug monitoring of beta-lactam antibiotics.

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.)

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