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PK of Meropenem in Patients on Plasma Exchange

Pharmacokinetics of Meropenem in Patients on Plasma Exchange

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05042271
Enrollment
15
Registered
2021-09-13
Start date
2020-01-01
Completion date
2022-12-31
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases

Keywords

therapeutic plasma exchange, meropenem, pharmacokinetic

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.

Interventions

DRUGmeropenem

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.

Sponsors

Prince of Songkla University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 administration0-8 hours after the drug administration

Secondary

MeasureTime 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

Countries

Thailand

Contacts

Primary ContactSutep Jaruratanasirikul, M.D.
jasutep@medicine.psu.ac.th66741485
Backup Contactmonchana Nawakitrangsan, M.Pharm
nana_jittung@hotmail.com66741585

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026