An observational study in Peritonitis Bacterial and Liver Cirrhosis, sponsored by Hannover Medical School. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Hannover Medical School · Observational
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.
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.
1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.
This study's planned enrollment of 15 is below the median of 152 across 605 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
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Patients in a tertiary care Hospital with meropenem therapy due to spontaneous bacterial Peritonitis.
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Exclusion Criteria:
Patients in a tertiary care Hospital with meropenem injection due to spontaneous bacterial Peritonitis.
Drug: Meropenem Injection
Meropenem is administered as prescribed by treating physician
Peak concentrations of meropenem in single- and multiple-dose pharmacokinetics
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.
Time frame: 5 days
Area under the curve of meropenem in single- and multiple-dose pharmacokinetics
Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of area under the curve characteristics
Time frame: 5 days
Trough concentrations of meropenem in single- and multiple-dose pharmacokinetics
Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of trough concentrations.
Time frame: 5 days
Time over MIC of meropenem in single- and multiple-dose pharmacokinetics
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.
Time frame: 5 days
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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