PK of Meropenem in Patients on Plasma Exchange

NCT05042271 | Unknown

• 1 other identifier: meropenem-plasma exchange
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autoimmune Diseases

Keywords

therapeutic plasma exchange; meropenem; pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

meropenem DRUG

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: Patients who underwent TPE (Phase 1); Meropenem: after TPE (Phase 2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

autoimmune diseases

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Faculty of Medicine, Prince of Songkla University, Thailand

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sutep Jaruratanasirikul, M.D.

  Faculty of Medicine, Prince of Songkla University, Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sutep Jaruratanasirikul, M.D.

CONTACT

66741485; jasutep@medicine.psu.ac.th

monchana Nawakitrangsan, M.Pharm

CONTACT

66741585; nana_jittung@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: September 13, 2021
• Study Start: January 1, 2020
• Primary Completion: October 18, 2021
• Study Completion: December 31, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

TH (1)