A pilot study for optimizing meropenem administration in the intensive care unit – short six times vs. prolonged three times courses daily

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

23 Jan 2025 → ongoing

Decision date (initial)

2025-01-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-520030-30-00

EudraCT number

2020-005066-34

ClinicalTrials.gov

NCT05578586

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy

The main objective is to demonstrate that meropenem given as 1 g in 15 minutes infusions 6 times daily is as good as the recommended dosing 2 g given during 3 hours 3 times daily.

Secondary objectives 2

1. The main objective is to demonstrate that meropenem given as 1 g in 15 minutes infusions 6 times daily is as good as the recommended dosing 2 g given during 3 hours 3 times daily.
2. To demonstrate that it is safe to be treated with meropenem 1 g in 15 minutes infusions 6 times daily versus the recommended dosing 2 g. during 3 hours infusions 3 times daily.

Conditions and MedDRA coding

Serious infection requiring broad-spectrum antibiotic

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Participants must be 18 years of age at inclusion to give informed consent
2. The participant must be admitted to the Intensive Care Unit at Oslo University Hospital, Rikshospitalet
3. The participant must have a condition with confirmed or suspected serious infection
4. There is indication for treatment with meropenem for at least 3 days
5. The patient or next of kin must give informed consent to participate in the study
6. 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.
7. 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 4

1. 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.
2. 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.
3. 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.
4. With the lack of informed consent after Day 1 after inclusion in the study, the patient cannot be included in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 4

1. 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
2. Lenght of stay in the intensive care unit.
3. Mortality 30 days after admission to the intensive care unit.
4. Serious adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Ingvild Nordøy

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Ingvild Nordøy

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications