NCT03571711

Meropenem Pharmacokinetics in Spontaneous Bacterial Peritonitis

Single- and Multiple-dose Pharmacokinetics of Meropenem in Spontaneous Bacterial Peritonitis and Liver Cirrhosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peritonitis Bacterial
• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Meropenem Injection	Meropenem is administered as prescribed by treating physician

Timeline

• Start date: 2018-06-28
• Primary completion: 2020-07-01
• Completion: 2021-01-01
• First posted: 2018-06-27
• Last updated: 2019-08-07

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study