Meropenem for Sepsis | Serious infection

Inclusion criteria

• {"criterion_text":"- 1.\tParticipants must be 18 years of age at inclusion to give informed consent\n- The participant must be admitted to the Intensive Care Unit at Oslo University Hospital, Rikshospitalet\n- The participant must have a condition with confirmed or suspected serious infection\n- There is indication for treatment with meropenem for at least 3 days\n- The patient or next of kin must give informed consent to participate in the study\n- Both genders can be included in the study. Fertile women , all women in the study who are not menopausal, i.e. over 12 months since last menstruation, must use contraception or a pregnancy test must be performed.\n- If the patient is awake and mentally orientated, the patient shall be asked for consent. If the patient is not able to consent due to sedation, intubation or the like, next of kin will be asked for consent, which may be delayed until the next day."}

Exclusion criteria

• {"criterion_text":"- If the participant has known hypersensitivity to meropenem or some of the additives to this drug or other drugs of the betalactam group of antibiotics.\n- If the patient are also treated with valproicacid/sodiumvalproat/valpromid, the participant shal be excluded from the study as these drugs increase the treshold for seizures.\n- If a women is pregnant, she cannot be included in the study. Fertile women must use contraceptives or have a negative pregnancy test to be included. Postmenopausal women, i.e. > 12 months since last menstruation, can be included.\n- With the lack of informed consent after Day 1 after inclusion in the study, the patient cannot be included in the study."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 50% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days","definition_or_measurement_approach":"Proportion of patients achieving meropenem concentration >2 mg/L for >50% of the time per day (50% T>MIC) assessed after days 1, 2 and 3 by measurement of meropenem blood concentrations."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 100% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days","definition_or_measurement_approach":"Proportion of patients achieving meropenem concentration >2 mg/L (reported in protocol as >100% of the time per day (50% T>MIC) after days 1, 2 and 3) assessed by meropenem blood levels."}
• {"endpoint_text":"- Lenght of stay in the intensive care unit.","definition_or_measurement_approach":"Duration of ICU stay measured in days from ICU admission to ICU discharge."}
• {"endpoint_text":"- Mortality 30 days after admission to the intensive care unit.","definition_or_measurement_approach":"All-cause mortality assessed at 30 days after ICU admission."}
• {"endpoint_text":"- Serious adverse events","definition_or_measurement_approach":"Occurrence of serious adverse events (SAEs) as per standard clinical trial safety reporting."}

Methods

• Recruitment of patients admitted to the Intensive Care Unit at Oslo University Hospital, Rikshospitalet (ICU in Norway); eligible ICU patients identified at admission and approached for consent (or next-of-kin consent if patient incapacitated).

Norway

Earliest CTIS Part Ii Submission Date

17-01-2025

Latest Decision Or Authorization Date

23-01-2025

Processing Time Days

6

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway