Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

Early Phase 1

Not yet recruiting

• Conditions: Infection, Bacterial
• Interventions: Device: Isothermal pouch

• Registration Number: NCT04809259
• Lead Sponsor: University of Lausanne Hospitals

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-21
• Study Start: 2024-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous infusion of meropenem	Isothermal pouch	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°

Primary Outcome Measures

Name	Time	Method
Proportion of plasma meropenem levels ≥ 4 mg/L	Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion	Blood will be drawn to determine meropenem plasma concentrations

Secondary Outcome Measures

Name	Time	Method
Volume administered by elastomeric pumps	Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion	Residual fluid volume in the elastomeric pumps
Allergic reactions or abnormal blood tests	Once a week through treatment completion	Number of patients who develop an allergic reaction or abnormal blood results, which will include full blood count, creatinine, alanine-aminotransferase (ALT)
Readmission	3 months after beginning of treatment	Number of patients who are unexpectedly readmitted to hospital
Cure or stabilisation of infection	3 months after beginning of treatment	Number of patients who are cured or have a stabilisation of the infection
Meropenem concentration in elastomeric pumps	Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion	Measurement of meropenem concentration in the elastomeric pumps