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

Bacteremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03108690
• Other study ID #: 2015-768
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: March 9, 2023

Study information

• Verified date: March 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia

Intervention

Drug:
• Continuous infusion of beta-lactam antibiotics .
Beta-lactam antibiotic will be administered as continous infusion.

Other:
• Therapeutic drug monitoring of beta-lactam antibiotics.
Dosage of beta-lactam antibiotics will be adjusted according to serum concentration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sara Thønnings

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Morbidity.	Diagnoses compared between the two arms.	30 days after intervention.
Secondary	Number of days until medically discharged.	Number of days until medically discharged compared between the two arms.	30 days after intervention.
Secondary	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.
Secondary	Amount of antibiotic used.	Defined daly doses of antibiotic therapy compared between the two arms.	30 days after intervention.
Secondary	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.
Secondary	Mortality.	30-day mortality compared between the two arms.	30 days after intervention.
Secondary	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.