Meropenem Pharmacokinetics in Spontaneous Bacterial Peritonitis

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571711
• Other study ID #: SBP-MER-PK-2018
• Status: Recruiting
• Start date: June 28, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: August 2019
• Source: Hannover Medical School
• Contact: Benjamin Maasoumy, PD Dr.
• Phone: +49 5115323378
• Email: maasoumy.benjamin[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Peritonitis
• Peritonitis Bacterial

Intervention

Drug:
• Meropenem Injection
Meropenem is administered as prescribed by treating physician

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 days
Primary	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	5 days
Primary	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.	5 days
Primary	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.	5 days