PK of Meropenem in Patients on Plasma Exchange

Pharmacokinetics of Meropenem in Patients on Plasma Exchange

Therapeutic plasma exchange (TPE) has been shown to be an important procedure for treatment of a variety of refractory immune complex disorders, such as Guillain-Barré syndrome and neuromyelitis optica. The intervention removes plasma, albumin, or some other substance. Meropenem is a broad-spectrum beta-lactam antimicrobial agent that is used for the treatment of serious nosocomial infections. Pathophysiological changes in patients on TPE can alter the pharmacokinetic (PK) patterns of coadministered antibiotics. This effect has an impact on the antimicrobial agents when paticipants are administered during the intervention. The aim of this study was to investigate the impact of TPE on meropenem PK.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Diseases
• Intervention / Treatment: Drug: meropenem

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

Contacts and Locations

• Study Contact: Name: Sutep Jaruratanasirikul, M.D.; Phone Number: 66741485; Email: jasutep@medicine.psu.ac.th
• Study Contact Backup: Name: monchana Nawakitrangsan, M.Pharm; Phone Number: 66741585; Email: nana_jittung@hotmail.com

Study Locations

• Thailand
  • Songkla
    • Hat Yai, Songkla, Thailand, 90110
      • Recruiting
      • Faculty of Medicine, Prince of Songkla University, Thailand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

autoimmune diseases

Description

Inclusion Criteria:

• age≥ 18 years
• no shock
• hemoglobin ≥ 7 g/dl

Exclusion Criteria:

• pregnancy or breast-feeding female
• history of hypersensitivity to carbapenems
• renal replacement therapy

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Meropenem: Patients who underwent TPE (Phase 1); In phase 1, each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first therapeutic plasma exchange (TPE) and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration.	Drug: meropenem; each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first TPE and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration.
Meropenem: after TPE (Phase 2); was similar to phase 1 except that the meropenem administration and PK studies were conducted >6 hours apart from the next TPE	Drug: meropenem; each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first TPE and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The plasma concentrations were measured at the following times: 0, 0.25, 0.5, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hour after the start of drug administration	0-8 hours after the drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration [Cmax]	0-8 hours after the drug administration
Minimum plasma concentration [Cmin]	0-8 hours after the drug administration
Area under the plasma concentration versus time curve [AUC]	0-8 hours after the drug administration
half-life [t1/2]	0-8 hours after the drug administration

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): October 18, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: therapeutic plasma exchange; meropenem; pharmacokinetic
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Meropenem
• Other Study ID Numbers: meropenem-plasma exchange

Drug and device information, study documents

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