Drug Effect
Conditions
Brief summary
Can antibiotic drugs be administered faster and make acceptable serum concentrations if we give short but multiple infusions compared to long and fewer infusions? In this study we will compare giving meropenem 1 gram 6 times daily in 15 minutes infusions to the recommended 2 gram 3 times daily in 3 hours infusions. In patients in the intensive care unit, the need for intravenous access is of essence. If 6 short infusions results in the same serum concentrations as 3 long infusions, we will increase intravenous access from 15 to 22.5 hours daily.
Detailed description
The primary aim of this pilot study is to examine if the dosing of the antibiotic meropenem given as 1 gram 6 times daily in 15 minutes infusions can be compared to 2 grams given 3 times daily in 3 hours infusion when measuring the serum concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l). The secondary aims are * That both administration forms will result in serum concentrations above MIC ≥ 100 % of the time (2 mg/l) * Days in hospital * 30 days mortality after admittance to the ICU * Serious side-effects Five extra blood samples will be performed 24, 48 and 72 hours between two dosing intervals. The dose will be adjusted according to renal function which will be monitored daily. The patients will be supervised for adverse effects until 2 days after treatment has stopped. The study will be performed from 2021 to the end of 2024.
Interventions
given as 6 or 3 infusions in 15 minues or 3 hours.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized pilotstudy 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 18 years admitted to the ICU at Oslo University Hospital, Rikshospitalet and 2. who shall be treated with meropenem because of proven or suspected serious infection and 3. who give their written informed consent either directly or through next of kin
Exclusion criteria
Patients 1. with known hypersensistivity to betalactam antibiotics or 2. who use of valproat or 3. who are pregnant or 4. the lack of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l) | After 24, 48 and 72 hours | Comparing 2 ways of administering meropenem intravenously |
Countries
Norway
Contacts
Primary ContactIngvild Nordøy, PhD
Backup ContactTrine Kåsine, PhD
Outcome results
None listed