Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

Infection, Bacterial Clinical Trial

Official title:

Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04809259
• Other study ID #: Meropenem 2021
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: January 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2023
• Source: University of Lausanne Hospitals
• Contact: Serge de Vallière, MD, MSc
• Phone: 0795564312
• Email: serge.de-valliere[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of plasma meropenem levels = 4 mg/L	Blood will be drawn to determine meropenem plasma concentrations	Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
Secondary	Cure or stabilisation of infection	Number of patients who are cured or have a stabilisation of the infection	3 months after beginning of treatment
Secondary	Readmission	Number of patients who are unexpectedly readmitted to hospital	3 months after beginning of treatment
Secondary	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)	Once a week through treatment completion
Secondary	Volume administered by elastomeric pumps	Residual fluid volume in the elastomeric pumps	Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
Secondary	Meropenem concentration in elastomeric pumps	Measurement of meropenem concentration in the elastomeric pumps	Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion