Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

NCT04809259 | Unknown Early Phase 1 DMC

• 1 other identifier: Meropenem 2021
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infection, Bacterial

Keywords

Meropenem; Outpatient parenteral antimicrobial therapy; Elastomeric pumps; Continuous infusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cure or stabilisation of infection

  3 months after beginning of treatment

• Readmission

  3 months after beginning of treatment

• Allergic reactions or abnormal blood tests

  Once a week through treatment completion

• Volume administered by elastomeric pumps

  Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion

• Meropenem concentration in elastomeric pumps

  Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion

Study Arms (1)

Continuous infusion of meropenem

EXPERIMENTAL

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

Interventions

Isothermal pouch 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.

Continuous infusion of meropenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Serge de Vallière

  de Vallière Serge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serge de Vallière, MD, MSc

CONTACT

0795564312; serge.de-valliere@chuv.ch

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 22, 2021
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share