Bacteraemia MedDRA version: 20.0 Level: LLT Classification code 10003998 Term: Bacteraemia, unspecified System Organ Class: 100000019999
Conditions
Interventions
Pharmaceutical Form: Infusion
INN or Proposed INN: BENZYLPENICILLIN SODIUM
CAS Number: 69-57-8
Other descriptive name: BENZYLPENICILLIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Hvidore Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Patients will be excluded if: - The positive blood culture is interpreted as contamination. - The patient dies before the intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. Determine the difference in the number of days until medically discharged between the two arms. 3. Determine the percentage of failed antibiotic treatments. 4. Determine the difference in the amount of antibiotic use between the two arms. 5. Determine the difference in antibiotic side effects and complications in patients between the two arms. 6. Determine the mortality between the two arms. 7. Identify any surrogate markers for patients in whom the serum concentrations do not correspond to the target values. ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30 days after inclusion of the last subject.;Secondary end point(s): 1. Diagnoses compared between the two arms. 2. The number of days until medically discharged compared between the two arms. 3. Change of antibiotic therapy compared between the two arms (A more narrow spectrum antibiotic treatment, is not considered to be a failure of antibiotic treatment). 4. Defined daily doses of antibiotic therapy compared between the two arms. 5. 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. 6. 30-day mortality compared between the two arms. 7. Clinical data (height, weight, heart rate, blood pressure, respiratory rate, Glasgow Coma Scale (GCS) score, temperature, focus of infection, the severity of bacteraemia, dialysis), biochemical data (hemoglobin, white blood cells, neutrophils, thrombocytes, C-reactive protein, sodium, potassium, creatinine, albumin, lactate dehydrogenase (LDH), Alanine Amino Transferase (ALAT) and lactate) compared between the two arms. | — |
Countries
Denmark
Contacts
Public ContactClinical Trials Information
Department of Clinical Microbiology
Outcome results
None listed