Clinical trial NCT03571711: Meropenem Pharmacokinetics in Spontaneous Bacterial Peritonitis
Official title: Single- and Multiple-dose Pharmacokinetics of Meropenem in Spontaneous Bacterial Peritonitis and Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritonitis Bacterial
Liver Cirrhosis
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in a tertiary care Hospital with meropenem therapy due to spontaneous bacterial Peritonitis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak concentrations of meropenem in single- and multiple-dose pharmacokinetics
timeFrame: 5 days
measure: Area under the curve of meropenem in single- and multiple-dose pharmacokinetics
timeFrame: 5 days
measure: Trough concentrations of meropenem in single- and multiple-dose pharmacokinetics
timeFrame: 5 days
measure: Time over MIC of meropenem in single- and multiple-dose pharmacokinetics
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Benjamin Maasoumy, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: