Clinical and microbiological efficacy of continuous versus intermittent application of meropenem in critically ill patients
| ISRCTN | ISRCTN26147641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26147641 |
| Protocol serial number | N/A |
| Sponsor | Charles University Teaching Hospital Plzen (Czech Republic) |
| Funder | Czech Ministry of Education (Czech Republic) ref: MSM0021620819 |
- Submission date
- 02/01/2012
- Registration date
- 20/01/2012
- Last edited
- 20/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
How well the antibiotic meropenem works depends on the dose used. The aim of this study was to compare the benefits of continuous infusion of meropenem against bolus administration (large dose given by injection in bloodstream to achieve the desired level rapidly), in critically ill patients, with severe infection.
Who can participate?
Patients aged 18 years or older (both men and women), admitted to the intensive care unit (ICU) of the university hospital, who suffered from severe infection .
What does the study involve?
Comparing continuous infusion of meropenem versus intermittent administration of meropenem given in higher daily dose. Patients were were randomly allocated to the Infusion group or the Bolus group.
What are the possible benefits and risks of participating?
We presumed that continuous infusion of meropenem could provide the same or better clinical and microbiological efficacy than intermittent administration of meropenem given in higher daily dose.
There were no additional risks in both groups.
Where is the study run from?
Department of Anesthesiology and Intensive Care Medicine at Charles University teaching hospital in Plzen, Czech Republic.
When is study starting and how long is it expected to run for?
The study started on 01/10/2007 and ended on 30/04/2010.
Who is funding the study?
Czech Ministry of Education (project ref: MSM0021620819).
Who is the main contact?
Dr Ivan Chytra
chytra@fnplzen.cz
Contact information
Scientific
Department of Anesthesia and Intensive Care
Charles University Teaching Hospital
Alej Svobody 80
Plzen
30460
Czech Republic
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center prospective randomized open-label comparative study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical and microbiological efficacy of continuous versus intermittent application of meropenem in critically ill patients: a randomized prospective single center study |
| Study objectives | Meropenem bactericidal activity depends on the time when the free drug concentrations remain above the minimum inhibitory concentration (MIC) of pathogens. In conventional bolus dosing regimens serum concentrations of meropenem between doses can fall to lower concentrations than MIC of less susceptible pathogens. We presume that continuous infusion of meropenem can provide the same or better clinical and microbiological efficacy than intermittent administration of meropenem given in higher daily dose. |
| Ethics approval(s) | Local Research Ethics Committee of University Hospital in Plzen, 17 May 2007 |
| Health condition(s) or problem(s) studied | Critically ill patients with severe infection |
| Intervention | Patients admitted to the intensive care (ICU) of university hospital who suffered from severe infection and received meropenem were randomized either in the Infusion group or in the Bolus group. Patients in the Infusion group received loading dose of 2g of meropenem followed by continuous infusion of 4g of meropenem over 24 hours. Patients in the Bolus group were given 2g of meropenem over 30 minutes every 8 hours. Clinical and microbiological outcome, meropenem-related length of ICU and hospital stay, meropenem-related length of mechanical ventilation, duration of meropenem treatment, total dose of meropenem, ICU and in-hospital mortality, safety and cost effectiveness were assessed. Patients were followed up to hospital discharge. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Clinical and microbiological efficacy of meropenem therapy were evaluated at the end of meropenem therapy |
| Key secondary outcome measure(s) |
1. Meropenem-related length of mechanical ventilation |
| Completion date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Key inclusion criteria | 1. Patients aged 18 years and over 2. Admitted to the interdisciplinary Intensive Care Unit (ICU) between September 2007 and May 2010 3. Had suffered from severe infection and received meropenem with predicted duration of treatment for at least 4 days at the admission or during the ICU stay 4. Types of infections include: 4.1. Abdominal 4.2. Respiratory 4.3. Skin 4.4. Soft tissue 4.5. Bloodstream 4.6. Central nervous system 4.7. Urinary tract 4.8. Other sources of infections |
| Key exclusion criteria | 1. Age younger than 18 years 2. Pregnancy 3. Acute or chronic renal failure with glomerular filtration rate lower than 0.5 ml/s 4. Immunodeficiency or immunosuppressant medication 5. Neutropenia 6. Hypersensitivity or allergy to meropenem |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 30/04/2010 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
30460
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |