Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-07 @ 6:11 PM
Study NCT ID:
NCT06717594
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2024-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* Serum samples for PK/PD analysis\n* Isolated bacterial strains'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2024-12-01', 'studyFirstSubmitQcDate': '2024-12-01', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK/PD efficacy targets for study drugs', 'timeFrame': 'From enrollment (treatment onset) to 48 and 72 hours after starting treatment', 'description': 'The primary endpoint will be the attainment of the pre-defined PK/PD target of efficacy at 48 and 72 hours after starting treatment for Carbapenem-resistant Enterobacterales (CRE) infection'}], 'secondaryOutcomes': [{'measure': 'Difference in SOFA score', 'timeFrame': 'From day 0 (day of index positive culture) and day 7', 'description': 'Difference in SOFA score between day 0 (day of treatment onset) and day 7'}, {'measure': 'Trend of C-Reactive Protein (CRP) and Procalcitonin (PCT)', 'timeFrame': 'From day 0 (day of index positive culture) and day 7', 'description': 'Trend of C-Reactive Protein (CRP) and Procalcitonin (PCT) from day 0 to day 7 after treatment onset'}, {'measure': 'Microbiological eradication', 'timeFrame': 'From day 0 (day of index positive culture) and day 7', 'description': 'Microbiological eradication defined as bacteraemia clearance or negativization of index diagnostic sample within 7 days from treatment onset'}, {'measure': 'Relapse and/or reinfection', 'timeFrame': 'From enrollment to the end of the follow-up at three months', 'description': 'Relapse (new infection with the same pathogen emerging after treatment) and/or reinfection (new infection with a different pathogen emerging after treatment) rates at day 90'}, {'measure': 'All-cause mortality', 'timeFrame': 'From enrollment to the end of the follow-up at three months', 'description': 'All-cause mortality at day 30 and at day 90'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gram negative infection', 'Ceftazidime/Avibactam', 'Fosfomycin', 'Pharmacokinetics/Pharmacodynamics targets', 'Carbapenem-resistant Enterobacterales (CRE)'], 'conditions': ['Gram Negative Infections', 'Antimicrobial Resistance (AMR)']}, 'descriptionModule': {'briefSummary': 'A multicenter international prospective observational pharmacological study in adult patients (≥18 years) treated with ceftazidime/avibactam (CAZ/AVI) alone or with CAZ/AVI plus fosfomycin (FOS) for infection due to carbapenem-resistant Enterobacterales (CRE) (KPC and/or OXA-48).', 'detailedDescription': 'Gram-negative infections, particularly those caused by carbapenem-resistant Enterobacterales (CRE), have a dramatic impact on patient survival. Despite the introduction of new drugs in the last years have improved the outcome of patients with CRE infections, mortality and relapse rates are still relevant, especially in patients with high-risk source as pneumonia, and those in which the attainment of optimal exposure could be reduced by underlying renal disease. The use of combination regimen in these scenarios has been proposed. However, a standardized approach is still missing. Since several in vitro studies have highlighted the synergistic effect of fosfomycin (FOS) with different antibiotic classes, including cephalosporins such drug could be an appealing option in combination therapy for the management of CRE infections.\n\nIn particular, the primary aim of the study is to assess the probability of achieving a pre-defined target of efficacy in patients treated with ceftazidime/avibactam (CAZ/AVI) and/or FOS according to different modes of drug administration in patients with CRE infections.\n\nSecondary aim is to assess the association between plasma drug concentration of both CAZ/AVI and FOS and patient response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with infection due to a difficult-to-treat Gram-negative bacteria, treated with CAZ/AVI alone or CAZ/AVI plus FOS, hospitalized during the study period in the participating centers, will be screened for inclusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signature of the informed consent\n* Age ≥ 18 years\n* Adult patients treated for ≥ 48 hours with CAZ/AVI or CAZ/AVI plus FOS for a microbiologically documented CRE infection\n\nExclusion Criteria:\n\n* Polymicrobial/mixed infections with exception of cases with multiple Enterobacterales susceptible to study drugs'}, 'identificationModule': {'nctId': 'NCT06717594', 'acronym': 'CAVIFOS', 'briefTitle': 'PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to Carbapenem-resistant Enterobacterales (CRE)', 'orgStudyIdInfo': {'id': 'CAVIFOS'}, 'secondaryIdInfos': [{'id': 'JPIAMR-ACTION', 'type': 'OTHER_GRANT', 'domain': 'Italian Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Carbapenem-resistant Enterobacterales (CRE) infection treated with CAZ/AVI ± FOS', 'description': 'Adult patients treated for ≥ 48 hours with CAZ/AVI or CAZ/AVI plus FOS for a microbiologically documented CRE infection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maddalena Giannella, MD PhD', 'role': 'CONTACT', 'email': 'maddalena.giannella@unibo.it', 'phone': '+390512143199'}], 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '41013', 'city': 'Seville', 'state': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando M Docobo Pérez, PhD', 'role': 'CONTACT', 'email': 'fdocobo1@us.es', 'phone': '+34 954118805'}], 'facility': 'Instituto de Biomedicina de Sevilla (IBiS), Hospital Virgen Macarena/CSIC/Universidad de Sevilla', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Maddalena Giannella, MD PhD', 'role': 'CONTACT', 'email': 'maddalena.giannella@unibo.it', 'phone': '+390512143199'}], 'overallOfficials': [{'name': 'Maddalena Giannella, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}