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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Proportion of plasma meropenem levels ≥ 4 mg/L
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
Cure or stabilisation of infection
Number of patients who are cured or have a stabilisation of the infection
Time frame: 3 months after beginning of treatment
Readmission
Number of patients who are unexpectedly readmitted to hospital
Time frame: 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)
Time frame: Once a week through treatment completion
Volume administered by elastomeric pumps
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
Meropenem concentration in elastomeric pumps
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
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