Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

Lausanne University Hospital (CHUV)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Infection, Bacterial

Treatments: Device: Isothermal pouch

Study type: Interventional

Funder types: Other

Identifiers

NCT04809259

Meropenem 2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Continuous infusion of meropenem

Experimental group

Description:

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°

Treatment:

Device: Isothermal pouch