A Pilot Study for Optimizing Meropenem Administration in the ICU
ConditionDrug Effect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years admitted to the ICU at Oslo University Hospital, Rikshospitalet and
who shall be treated with meropenem because of proven or suspected serious infection and
who give their written informed consent either directly or through next of kin
Disqualifiers
with known hypersensistivity to betalactam antibiotics or
who use of valproat or
who are pregnant or
the lack of consent.
Trial design
Design model
Parallel
Treatments tested in this trial
Meropenem 1000 mg
Druggiven as 6 or 3 infusions in 15 minues or 3 hours.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Experimental vs ControlExperimental treatment 1 intervention
Group B: ControlsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l)
Comparing 2 ways of administering meropenem intravenously
Time frame
After 24, 48 and 72 hoursSponsors and contacts
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Source ClinicalTrials.gov