search
Back to results

Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

Primary Purpose

Infection, Bacterial

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Isothermal pouch
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Bacterial focused on measuring Meropenem, Outpatient parenteral antimicrobial therapy, Elastomeric pumps, Continuous infusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Continuous infusion of meropenem

    Arm 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°

    Outcomes

    Primary Outcome Measures

    Proportion of plasma meropenem levels ≥ 4 mg/L
    Blood will be drawn to determine meropenem plasma concentrations

    Secondary Outcome Measures

    Cure or stabilisation of infection
    Number of patients who are cured or have a stabilisation of the infection
    Readmission
    Number of patients who are unexpectedly readmitted to hospital
    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)
    Volume administered by elastomeric pumps
    Residual fluid volume in the elastomeric pumps
    Meropenem concentration in elastomeric pumps
    Measurement of meropenem concentration in the elastomeric pumps

    Full Information

    First Posted
    February 3, 2021
    Last Updated
    August 22, 2022
    Sponsor
    University of Lausanne Hospitals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04809259
    Brief Title
    Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch
    Official Title
    Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Lausanne Hospitals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Bacterial
    Keywords
    Meropenem, Outpatient parenteral antimicrobial therapy, Elastomeric pumps, Continuous infusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous infusion of meropenem
    Arm Type
    Experimental
    Arm 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°
    Intervention Type
    Device
    Intervention Name(s)
    Isothermal pouch
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Proportion of plasma meropenem levels ≥ 4 mg/L
    Description
    Blood will be drawn to determine meropenem plasma concentrations
    Time Frame
    Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
    Secondary Outcome Measure Information:
    Title
    Cure or stabilisation of infection
    Description
    Number of patients who are cured or have a stabilisation of the infection
    Time Frame
    3 months after beginning of treatment
    Title
    Readmission
    Description
    Number of patients who are unexpectedly readmitted to hospital
    Time Frame
    3 months after beginning of treatment
    Title
    Allergic reactions or abnormal blood tests
    Description
    Number of patients who develop an allergic reaction or abnormal blood results, which will include full blood count, creatinine, alanine-aminotransferase (ALT)
    Time Frame
    Once a week through treatment completion
    Title
    Volume administered by elastomeric pumps
    Description
    Residual fluid volume in the elastomeric pumps
    Time Frame
    Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
    Title
    Meropenem concentration in elastomeric pumps
    Description
    Measurement of meropenem concentration in the elastomeric pumps
    Time Frame
    Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Serge de Vallière, MD, MSc
    Phone
    0795564312
    Email
    serge.de-valliere@chuv.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Serge de Vallière
    Organizational Affiliation
    de Vallière Serge
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

    We'll reach out to this number within 24 hrs