NCT03108690

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Longer than P75 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

5.4 years

First QC Date

March 30, 2017

Last Update Submit

March 27, 2023

Conditions

Bacteremia

Keywords

Therapeutic drug monitoringContinuous infusionBeta-lactamAntibioticsBacteraemia

Outcome Measures

Primary Outcomes (1)

  • Target concentrations.

    Serum concentrations within the target values for intervention. Following beta-lactams is included in the study: Benzylpenicillin, ampicillin, dicloxacillin, piperacillin/tazobactam, cefuroxime and meropenem.

    30 days after intervention.

Secondary Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Study Arms (2)

TDM and CI.

EXPERIMENTAL

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

Drug: Continuous infusion of beta-lactam antibiotics .Other: Therapeutic drug monitoring of beta-lactam antibiotics.

Control

NO INTERVENTION

Beta-lactam antibiotics given as intermittent infusion. Samples of serum concentration of beta-lactam will be collected for comparison, but blinded during the study.

Interventions

Continuous infusion of beta-lactam antibiotics .DRUG

Beta-lactam antibiotic will be administered as continous infusion.

Also known as: Benzylpenicillin, Ampicillin, Dicloxacillin, Piperacillin/tazobactam, Cefuroxime, Meropenem
TDM and CI.
Therapeutic drug monitoring of beta-lactam antibiotics.OTHER

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

TDM and CI.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Positive blood culture is interpreted as contamination.
  • The patient dies before the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BacteremiaToxemia

Interventions

Penicillin GAmpicillinDicloxacillinPiperacillin, Tazobactam Drug CombinationCefuroximeMeropenem

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Penicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCloxacillinOxacillinTazobactamPenicillanic AcidPiperacillinSulfonesDrug CombinationsPharmaceutical PreparationsCephalosporinsThiazinesThienamycinsCarbapenems

Study Officials

  • Sara Thønnings, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 11, 2017

Study Start

October 1, 2017

Primary Completion

March 9, 2023

Study Completion

March 9, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03