Infection, Bacterial
Conditions
Keywords
Meropenem, Outpatient parenteral antimicrobial therapy, Elastomeric pumps, Continuous infusion
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.
Interventions
DEVICEIsothermal 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.
Sponsors
University of Lausanne Hospitals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of plasma meropenem levels ≥ 4 mg/L | Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion | Blood will be drawn to determine meropenem plasma concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cure or stabilisation of infection | 3 months after beginning of treatment | Number of patients who are cured or have a stabilisation of the infection |
| Readmission | 3 months after beginning of treatment | Number of patients who are unexpectedly readmitted to hospital |
| Allergic reactions or abnormal blood tests | Once a week through treatment completion | 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 | Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion | Residual fluid volume in the elastomeric pumps |
| Meropenem concentration in elastomeric pumps | Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion | Measurement of meropenem concentration in the elastomeric pumps |
Contacts
Primary ContactSerge de Vallière, MD, MSc
Outcome results
None listed