Clinical and microbiological efficacy of continuous versus intermittent application of meropenem in critically ill patients

Clinical and microbiological efficacy of continuous versus intermittent application of meropenem in critically ill patients: a randomized prospective single center study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26147641

Enrollment

240

Registered

2012-01-20

Start date

2007-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill patients with severe infection Infections and Infestations

Interventions

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. Pat

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Clinical and microbiological efficacy of meropenem therapy were evaluated at the end of meropenem therapy Clinical response was evaluated at the end of therapy as treatment success or failure. Clinical success was defined as complete or partial resolution of leukocytosis, temperature, and clinical signs and symptoms of infection. Cure was defined as complete resolution of all acute signs and symptoms of infection, with no new signs or symptoms associated with the original infection. Patients who retained evidence of infection but demonstrated a reduction of the majority of the clinical signs and symptoms of infection and no new or worsened signs associated with the original infection were classified as improved. For the purpose of statistical analysis, patients meeting the definitions of cured and improved were combined and defined as clinical successes. Failure consisted of any of the following: 1.1. Persistence or progression of signs and symptoms of infection 1.2. Development of new clinical findings consistent with active infection 1.3. Death from infection 2. Microbiological outcome was assigned one of the following categories: eradication, presumed eradication, persistence, presumed persistence, resistance or unevaluable. Eradication was defined as elimination of the pathogen from the site of isolation. Presumed eradication consisted of absence of appropriate material for culture or absence of results of control microbiological tests coupled with clinical improvement after a pathogen was initially isolated. Three possible outcomes were defined collectively as persistence: verified persistence (failure to eradicate the original pathogen from the site of isolation after completion of therapy), presumed persistence (absence of appropriate material for culture or absence of results of control microbiological tests coupled with lack of clinical improvement after a pathogen was initially isolated) and development of resistance during therapy. Patients without c	—

Measure

Time frame

1. Clinical and microbiological efficacy of meropenem therapy were evaluated at the end of meropenem therapy Clinical response was evaluated at the end of therapy as treatment success or failure. Clinical success was defined as complete or partial resolution of leukocytosis, temperature, and clinical signs and symptoms of infection. Cure was defined as complete resolution of all acute signs and symptoms of infection, with no new signs or symptoms associated with the original infection. Patients who retained evidence of infection but demonstrated a reduction of the majority of the clinical signs and symptoms of infection and no new or worsened signs associated with the original infection were classified as improved. For the purpose of statistical analysis, patients meeting the definitions of cured and improved were combined and defined as clinical successes. Failure consisted of any of the following: 1.1. Persistence or progression of signs and symptoms of infection 1.2. Development of new clinical findings consistent with active infection 1.3. Death from infection 2. Microbiological outcome was assigned one of the following categories: eradication, presumed eradication, persistence, presumed persistence, resistance or unevaluable. Eradication was defined as elimination of the pathogen from the site of isolation. Presumed eradication consisted of absence of appropriate material for culture or absence of results of control microbiological tests coupled with clinical improvement after a pathogen was initially isolated. Three possible outcomes were defined collectively as persistence: verified persistence (failure to eradicate the original pathogen from the site of isolation after completion of therapy), presumed persistence (absence of appropriate material for culture or absence of results of control microbiological tests coupled with lack of clinical improvement after a pathogen was initially isolated) and development of resistance during therapy. Patients without c

—

Secondary

Measure	Time frame
1. Meropenem-related length of mechanical ventilation 2. Meropenem-related length of ICU and hospital stay (LOS) 3. ICU and in-hospital mortality 4. Duration of meropenem treatment 5. The total dose of meropenem 6. Safety and cost effectiveness of both dosing regimens	—

Countries

Czech Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026