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Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

NCT ID: NCT04809259

Last Updated: 2023-12-21

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

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-04-30

Brief Summary

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This study aims to evaluate if meropenem can be administered in outpatients as a continuous infusion using elastomeric pumps and an isothermal pouch maintaining the anti-infective solution between 10° and 15°C for improved stability.

Detailed Description

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The Outpatient Parenteral Antibiotic Therapy (OPAT) unit of the University Hospital of Lausanne uses elastomeric pumps for continuous intravenous administration of 6 different antibiotics. This mode of administration is possible for all antibiotics with a time-dependent bactericidal effect.

Meropenem belongs to this class of antibiotics, but is not stable at room temperature in elastomeric pumps. However, this antibiotic is stable at 10°C and 15°C. The investigators have therefore developed an isothermal pouch that allows the anti-infective solution to be maintained at a temperature between 10 and 15°C over 24 hours.

This study aims to evaluate the efficacy and safety of meropenem administration using an elastomeric pump maintained at a temperature between 10° and 15°C by an isothermal pouch.

The possibility of being able to administer meropenem by elastomeric pumps would greatly facilitate the ambulatory management of patients requiring treatment with this anti-infective drug.

Conditions

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Infection, Bacterial

Keywords

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Meropenem Outpatient parenteral antimicrobial therapy Elastomeric pumps Continuous infusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous infusion of meropenem

The meropenem solution will be administered continuously using elastomeric pumps which will be changed every 24 hours and which will be inserted in an isothermal pouch to ensure that the antibiotic solution is maintained at a temperature between 10° and 15°

Group Type EXPERIMENTAL

Isothermal pouch

Intervention Type DEVICE

The study will verify it the use of an isothermal pouch to maintain the content of an elastomeric pump at 10° to 15°C avoids unacceptable meropenem degradation over the 24 hour infusion period.

Interventions

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Isothermal pouch

The study will verify it the use of an isothermal pouch to maintain the content of an elastomeric pump at 10° to 15°C avoids unacceptable meropenem degradation over the 24 hour infusion period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients referred to the OPAT unit for a anti-microbial treatment with meropenem
* Age ≥ 18 years
* Informed consent signed

Exclusion Criteria

* Patients refusing a PICC-line
* Pregnancy or desire of a pregnancy
* Patients considered to be not eligible for outpatient treatment by the OPAT team
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Serge de Valliere

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serge de Vallière

Role: PRINCIPAL_INVESTIGATOR

de Vallière Serge

Central Contacts

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Serge de Vallière, MD, MSc

Role: CONTACT

Phone: 0795564312

Email: [email protected]

Other Identifiers

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Meropenem 2021

Identifier Type: -

Identifier Source: org_study_id