Meropenem Pharmacokinetics in Spontaneous Bacterial Peritonitis

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Peritonitis Bacterial
• Intervention / Treatment: Drug: Meropenem Injection

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.

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Benjamin Maasoumy, PD Dr.; Phone Number: +49 5115323378; Email: maasoumy.benjamin@mh-hannover.de
• Study Contact Backup: Name: Julius J Schmidt, Dr.; Email: schmidt.julius@mh-hannover.de

Study Locations

• Germany
  • Hannover, Germany
    • Recruiting
    • Hannover Medical School
    • Contact: Julius J Schmidt; Email: schmidt.julius@mh-hannover.de
    • Sub-Investigator: Julius J Schmidt
    • Principal Investigator: Benjamin Maasoumy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Meropenem therapy in SBP; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Benjamin Maasoumy, PD Dr., Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Peritoneal Diseases; Liver Diseases; Intraabdominal Infections; Fibrosis; Liver Cirrhosis; Peritonitis; Anti-Infective Agents; Anti-Bacterial Agents; Meropenem
• Other Study ID Numbers: SBP-MER-PK-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No