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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05042271
Other study ID # meropenem-plasma exchange
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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