PK of Meropenem in Patients on Plasma Exchange

Autoimmune Diseases Clinical Trial

Official title:

Pharmacokinetics of Meropenem in Patients on Plasma Exchange

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042271
• Other study ID #: meropenem-plasma exchange
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Prince of Songkla University
• Contact: Sutep Jaruratanasirikul, M.D.
• Phone: 66741485
• Email: jasutep[@]medicine.psu.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2022
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University, Thailand	Hat Yai	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum plasma concentration [Cmax]		0-8 hours after the drug administration
Secondary	Minimum plasma concentration [Cmin]		0-8 hours after the drug administration
Secondary	Area under the plasma concentration versus time curve [AUC]		0-8 hours after the drug administration
Secondary	half-life [t1/2]		0-8 hours after the drug administration