Infection, BacterialEarly Phase 1NCT04809259
Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch
A Early Phase 1 study testing Isothermal pouch in people with Infection, Bacterial, run by University of Lausanne Hospitals.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Isothermal pouch
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Apr 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to the OPAT unit for a anti-microbial treatment with meropenem
- Age ≥ 18 years
- Informed consent signed
Who cannot join
- Patients refusing a PICC-line
- Pregnancy or desire of a pregnancy
- Patients considered to be not eligible for outpatient treatment by the OPAT team
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Isothermal pouch
- Keywords
- Meropenem, Outpatient parenteral antimicrobial therapy, Elastomeric pumps, Continuous infusion
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isothermal pouchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion of meropenem | Experimental | The meropenem solution will be administered continuously using elastomeric pumps which will be changed every 24 hours and which will be inserted in an isothermal pouch to ensure that the antibiotic solution is maintained at a temperature between 10° and 15° Receives: Device: Isothermal pouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of plasma meropenem levels ≥ 4 mg/L
Blood will be drawn to determine meropenem plasma concentrations
Measured: Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
Secondary outcomes (5)
Cure or stabilisation of infection
Number of patients who are cured or have a stabilisation of the infection
Measured: 3 months after beginning of treatment
Readmission
Number of patients who are unexpectedly readmitted to hospital
Measured: 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)
Measured: Once a week through treatment completion
Volume administered by elastomeric pumps
Residual fluid volume in the elastomeric pumps
Measured: 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
Measured: Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serge de Valliere, University of Lausanne Hospitals
- Investigators
- Serge de Vallière, Principal investigator, de Vallière Serge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809259
- Sponsor's protocol ID
- Meropenem 2021
- Status last verified
- Dec 2023
- First submitted
- 3 Feb 2021
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch
- ClinicalTrials.gov ID
- NCT04809259
- Acronym / sponsor ID
- Meropenem 2021
- Conditions
- Infection, Bacterial
- Keywords
- Meropenem, Outpatient parenteral antimicrobial therapy, Elastomeric pumps, Continuous infusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion of meropenem | Experimental | Device: Isothermal pouchThe meropenem solution will be administered continuously using elastomeric pumps which will be changed every 24 hours and which will be inserted in an isothermal pouch to ensure that the antibiotic solution is maintained at a temperature between 10° and 15° |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred to the OPAT unit for a anti-microbial treatment with meropenem
- Age ≥ 18 years
- Informed consent signed
Key exclusion criteria (3 listed)
- Patients refusing a PICC-line
- Pregnancy or desire of a pregnancy
- Patients considered to be not eligible for outpatient treatment by the OPAT team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isothermal pouchThe 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. | Device | Continuous infusion of meropenem |
Primary outcome
Proportion of plasma meropenem levels ≥ 4 mg/L
Time frame: 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
5 secondary outcomes
Cure or stabilisation of infection
Time frame: 3 months after beginning of treatment
Readmission
Time frame: 3 months after beginning of treatment
Allergic reactions or abnormal blood tests
Time frame: Once a week through treatment completion
Volume administered by 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
Time frame: Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge de Vallière principal investigator
de Vallière Serge
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Isothermal pouch in people with Infection, Bacterial, run by University of Lausanne Hospitals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serge de Vallière, MD, MSc (0795564312, serge.de-valliere@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of plasma meropenem levels ≥ 4 mg/L (time frame: Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.