Therapeutic drug monitoring and continuous infusion of antibiotics (beta-lactams) in patients with blood poisoning.

Phase 1

• Conditions: Bacteraemia; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 20.0Level: LLTClassification code 10003998Term: Bacteraemia, unspecifiedSystem Organ Class: 100000019999

• Registration Number: EUCTR2015-002562-23-DK
• Lead Sponsor: Hvidore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-21
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients must meet following inclusion criteria:
- Have a positive blood culture.
- Undergo treatment with either intravenous penicillin, ampicillin, piperacillin / tazobactam, dicloxacillin, cefuroxime or meropenem.
- Hospitalised at Hvidovre Hospital.
- Age = 18 years.
- Able to understand and give informed consent.
- Included in the study within 24 hours after the final positive blood culture answer.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

Patients will be excluded if:
- The positive blood culture is interpreted as contamination.
- The patient dies before the intervention.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.;Secondary Objective: 1. Determine the morbidity between the two arms.<br>2. Determine the difference in the number of days until medically discharged between the two arms.<br>3. Determine the percentage of failed antibiotic treatments.<br>4. Determine the difference in the amount of antibiotic use between the two arms.<br>5. Determine the difference in antibiotic side effects and complications in patients between the two arms.<br>6. Determine the mortality between the two arms.<br>7. Identify any surrogate markers for patients in whom the serum concentrations do not correspond to the target values.<br>;Primary end point(s): Serum concentrations within the target values for intervention.;Timepoint(s) of evaluation of this end point: 30 days after inclusion of the last subject.