PK of Meropenem in Patients on Plasma Exchange

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics of Meropenem in Patients on Plasma Exchange

Conditions
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Autoimmune Diseases

Intervention / Treatment
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* Drug: meropenem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Meropenem: Patients who underwent TPE (Phase 1)<br>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<br>* 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.<br>|
| Meropenem: after TPE (Phase 2)<br>was similar to phase 1 except that the meropenem administration and PK studies were conducted >6 hours apart from the next TPE | Drug: meropenem<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic plasma exchange, meropenem, pharmacokinetic