Clinical trial NCT04809259: 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
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Infection, Bacterial
Keywords: Meropenem
Outpatient parenteral antimicrobial therapy
Elastomeric pumps
Continuous infusion
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of plasma meropenem levels ≥ 4 mg/L
timeFrame: Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
Secondary outcomes:
measure: Cure or stabilisation of infection
timeFrame: 3 months after beginning of treatment
measure: Readmission
timeFrame: 3 months after beginning of treatment
measure: Allergic reactions or abnormal blood tests
timeFrame: Once a week through treatment completion
measure: Volume administered by elastomeric pumps
timeFrame: Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
measure: Meropenem concentration in elastomeric pumps
timeFrame: Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
Other outcomes:
Locations:
Study officials:
affiliation: de Vallière Serge
name: Serge de Vallière
role: PRINCIPAL_INVESTIGATOR
References: