NCT04809259

Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection, Bacterial

Interventions

Type	Name	Description
DEVICE	Isothermal 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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-31
• Completion: 2025-04-30
• First posted: 2021-03-22
• Last updated: 2023-12-21