Meropenem Pharmacokinetics in Spontaneous Bacterial Peritonitis

Hannover Medical School (MHH)

Status: Unknown

Conditions: Peritonitis Bacterial; Liver Cirrhosis

Treatments: Drug: Meropenem Injection

Study type: Observational

Funder types: Other

Identifiers

NCT03571711

SBP-MER-PK-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Meropenem therapy in SBP

Description:

Patients in a tertiary care Hospital with meropenem injection due to spontaneous bacterial Peritonitis.

Treatment:

Drug: Meropenem Injection