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

The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.

Study Overview

• Status: Withdrawn
• Conditions: Bacteremia
• Intervention / Treatment: Drug: Continuous infusion of beta-lactam antibiotics .; Other: Therapeutic drug monitoring of beta-lactam antibiotics.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sara Thønnings, MD; Phone Number: +45 38621783; Email: sara.thoennings@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TDM and CI.; Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics.	Drug: Continuous infusion of beta-lactam antibiotics .; Beta-lactam antibiotic will be administered as continous infusion.; Other Names: Meropenem; Ampicillin; Cefuroxime; Piperacillin/tazobactam; Benzylpenicillin; Dicloxacillin; Other: Therapeutic drug monitoring of beta-lactam antibiotics.; Dosage of beta-lactam antibiotics will be adjusted according to serum concentration.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity.	Diagnoses compared between the two arms.	30 days after intervention.
Number of days until medically discharged.	Number of days until medically discharged compared between the two arms.	30 days after intervention.
Failed antibiotic treatments.	Adding an additional antibiotic and/or change to a different antibiotic (not including a more narrow spectrum antibiotic) compared between the two arms.	30 days after intervention.
Amount of antibiotic used.	Defined daly doses of antibiotic therapy compared between the two arms.	30 days after intervention.
Antibiotic side effects and complications.	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.	30 days after intervention.
Mortality.	30-day mortality compared between the two arms.	30 days after intervention.
Number of participants with abnormal clinical data and/or abnormal laboratory values.	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.	30 days after intervention.

Collaborators and Investigators

• Sponsor: Sara Thønnings
• Investigators: Principal Investigator: Sara Thønnings, MD, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Antibiotics; Therapeutic drug monitoring; Bacteraemia; Beta-lactam; Continuous infusion
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antitubercular Agents; beta-Lactamase Inhibitors; Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Meropenem; Cefuroxime; Piperacillin; Penicillin G; Tazobactam; Piperacillin, Tazobactam Drug Combination; Dicloxacillin; Lactams; beta-Lactams
• Other Study ID Numbers: 2015-768

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No