Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-28 @ 9:14 AM
Study NCT ID:
NCT04809259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-21
First Post:
2021-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch
Sponsor:
University of Lausanne Hospitals
Organization:
Study Overview
Official Title:
Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: