Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

Study Overview
=================
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.

Official Title
-----------------
Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

Conditions
-----------------
Infection, Bacterial

Intervention / Treatment
-----------------
* Device: Isothermal pouch


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous infusion of meropenem<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meropenem, Outpatient parenteral antimicrobial therapy, Elastomeric pumps, Continuous infusion