NCT03571711

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 28, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

May 28, 2018

Last Update Submit

August 6, 2019

Conditions

Peritonitis BacterialLiver Cirrhosis

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Meropenem therapy in SBP

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

Drug: Meropenem Injection

Interventions

Meropenem InjectionDRUG

Meropenem is administered as prescribed by treating physician

Meropenem therapy in SBP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 18 - 75 years
  • Administration of meropenem
  • Diagnosis of liver cirrhosis
  • Diagnosis of spontaneous bacterial Peritonitis
  • Indication for peritoneal drainage catheter

You may not qualify if:

  • Incapacity to give informed consent
  • Participation in other studies
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Plasma and ascites samples are taken before 30, 60, 120, 240, 480, 510, 540, 600, 720, 960, 990, 1020, 1080, 1200 and 1440 minutes after the first meropenem Infusion at day one and four after study enrollment.

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Benjamin Maasoumy, PD Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Maasoumy, PD Dr.

CONTACT

+49 5115323378maasoumy.benjamin@mh-hannover.de

Julius J Schmidt, Dr.

CONTACT

schmidt.julius@mh-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 27, 2018

Study Start

June 28, 2018

Primary Completion

July 1, 2020

Study Completion

January 1, 2021

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

DE(1)