Peritonitis Bacterial, Liver Cirrhosis
Conditions
Brief summary
The emergence of multidrug-resistant bacteria has increased the use of meropenem in spontaneous bacterial peritonitis (SBP). Additionally, recent studies suggested female gender as an independent risk factor for mortality in SBP. Studies regarding possible sex dependent differences in meropenem pharmacokinetics in SBP are scarce. The aim of this study is to determine the pharmacokinetics of meropenem during SBP in female and male patients with liver cirrhosis to investigate whether pharmacodynamics therapy goals are met.
Detailed description
Spontaneous bacterial Peritonitis (SBP) in liver cirrhosis is a severe and increasingly common disease, which is associated with high morbidity, mortality and high costs for the investigator's health care system. In addition to age and severity of comorbidities, female sex is associated with detrimental outcome. Delayed diagnosis and therapy of SBP may lead to a higher mortality in this patient population. Therefore, an early diagnosis and adequate anti-infective therapy is essential. Due to the accumulation of antimicrobial-resistant (AMR) pathogens, especially in nosocomial SBP, empirical application of broad-spectrum antibiotics is recommended in the therapy of SBP.During the use of antibiotic drugs in general, pharmacokinetic/pharmacodynamic (PK/PD) targets, as the achieved time period over the minimal inhibitory concentration (MIC), should be evaluated to increase drug efficacy and reduce AMR development. Pharmacokinetic studies of meropenem concentrations at the infection site in this particular group of patients are rare in the literature. Recent studies in critically ill patients showed highly variable meropenem concentrations in peritoneal fluid after iv administration. The aim of this study is to determine the pharmacokinetics of meropenem during SBP in female and male patients with liver cirrhosis to investigate whether pharmacodynamics therapy goals are met.
Interventions
Meropenem is administered as prescribed by treating physician
Sponsors
Hannover Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 75 years * Administration of meropenem * Diagnosis of liver cirrhosis * Diagnosis of spontaneous bacterial Peritonitis * Indication for peritoneal drainage catheter
Exclusion criteria
* Incapacity to give informed consent * Participation in other studies * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak concentrations of meropenem in single- and multiple-dose pharmacokinetics | 5 days | Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of Peak Levels concentrations in blood plasma and ascites fluid and evaluation of peak concentrations. |
| Area under the curve of meropenem in single- and multiple-dose pharmacokinetics | 5 days | Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of area under the curve characteristics |
| Trough concentrations of meropenem in single- and multiple-dose pharmacokinetics | 5 days | Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of trough concentrations. |
| Time over MIC of meropenem in single- and multiple-dose pharmacokinetics | 5 days | Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of achieved time period with drug concentration above the minimal inhibitory concentration breakpoint of 8 mg/L. |
Countries
Germany
Contacts
Primary ContactBenjamin Maasoumy, PD Dr.
Backup ContactJulius J Schmidt, Dr.
Outcome results
None listed