Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infection, Bacterial
• Intervention / Treatment: Device: Isothermal pouch

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Serge de Vallière, MD, MSc; Phone Number: 0795564312; Email: serge.de-valliere@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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°	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Serge de Vallière, de Vallière Serge

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Meropenem; Continuous infusion; Outpatient parenteral antimicrobial therapy; Elastomeric pumps
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: Meropenem 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No