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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-03-18', 'lastUpdatePostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of plasma meropenem levels ≥ 4 mg/L', 'timeFrame': 'Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion', 'description': 'Blood will be drawn to determine meropenem plasma concentrations'}], 'secondaryOutcomes': [{'measure': 'Cure or stabilisation of infection', 'timeFrame': '3 months after beginning of treatment', 'description': 'Number of patients who are cured or have a stabilisation of the infection'}, {'measure': 'Readmission', 'timeFrame': '3 months after beginning of treatment', 'description': 'Number of patients who are unexpectedly readmitted to hospital'}, {'measure': 'Allergic reactions or abnormal blood tests', 'timeFrame': 'Once a week through treatment completion', 'description': 'Number of patients who develop an allergic reaction or abnormal blood results, which will include full blood count, creatinine, alanine-aminotransferase (ALT)'}, {'measure': 'Volume administered by elastomeric pumps', 'timeFrame': 'Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion', 'description': 'Residual fluid volume in the elastomeric pumps'}, {'measure': 'Meropenem concentration in elastomeric pumps', 'timeFrame': 'Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion', 'description': 'Measurement of meropenem concentration in the elastomeric pumps'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meropenem', 'Outpatient parenteral antimicrobial therapy', 'Elastomeric pumps', 'Continuous infusion'], 'conditions': ['Infection, Bacterial']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMeropenem 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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to the OPAT unit for a anti-microbial treatment with meropenem\n* Age ≥ 18 years\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patients refusing a PICC-line\n* Pregnancy or desire of a pregnancy\n* Patients considered to be not eligible for outpatient treatment by the OPAT team'}, 'identificationModule': {'nctId': 'NCT04809259', 'briefTitle': 'Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch', 'orgStudyIdInfo': {'id': 'Meropenem 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous infusion of meropenem', 'description': '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°', 'interventionNames': ['Device: Isothermal pouch']}], 'interventions': [{'name': 'Isothermal pouch', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Continuous infusion of meropenem']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Serge de Vallière, MD, MSc', 'role': 'CONTACT', 'email': 'serge.de-valliere@chuv.ch', 'phone': '0795564312'}], 'overallOfficials': [{'name': 'Serge de Vallière', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'de Vallière Serge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Serge de Valliere', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}