PK of Meropenem in Patients on Plasma Exchange

NCT ID: NCT05042271

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Autoimmune Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

meropenem

Intervention Type 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: 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

meropenem

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Sutep Jaruratanasirikul

Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sutep Jaruratanasirikul, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Prince of Songkla University, Thailand

Locations

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Faculty of Medicine, Prince of Songkla University, Thailand

Hat Yai, Changwat Songkhla, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Sutep Jaruratanasirikul, M.D.

Role: CONTACT

monchana Nawakitrangsan, M.Pharm

Role: CONTACT

Facility Contacts

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Sutep Jaruratanasirikul, M.D.

Role: primary

6674-451485

Monchana Nawakitrangsan, M.Pharm

Role: backup

6674-451486

Other Identifiers

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meropenem-plasma exchange

Identifier Type: -

Identifier Source: org_study_id

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