Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-02-18 @ 1:11 PM
Study NCT ID:
NCT06214403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-04
First Post:
2023-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': '180 days', 'description': 'Frequency and grade'}, {'measure': '90- and 180-day infection rate', 'timeFrame': '180 days', 'description': 'Infection will be defined as either isolation of a pathogenic species from any sterile site OR the initiation of a therapeutic course of antimicrobials with or without isolation of a pathogenic species from a sterile or non-sterile site'}, {'measure': 'ARO colonization by culture at 30 and 90 days post-intervention', 'timeFrame': '90 days', 'description': 'Defined as any positive result for ARO from any site'}, {'measure': 'Determine 90- and 180-day recurrence/re-infection rates (with the same organism) in each treatment arm', 'timeFrame': '180 days'}, {'measure': 'AMR gene complement by sequencing at 30 and 90 days post-intervention', 'timeFrame': '90 days'}, {'measure': '90- and 180-day all-cause mortality', 'timeFrame': '180 days'}, {'measure': 'ICU and hospital lengths of stay', 'timeFrame': '180 days'}, {'measure': 'C. difficile carriage at days 30 and 90', 'timeFrame': '90 days'}], 'primaryOutcomes': [{'measure': 'Recruitment rate overall and by study site', 'timeFrame': '1.5 years', 'description': 'Defined by the numbers of eligible, consented, and randomized patients'}, {'measure': 'Adherence to MET-2/placebo for the treatment duration', 'timeFrame': '30 days', 'description': 'Defined as \\>80% of loading dose (16/20 pills) + \\>75% of daily doses (18/24 pills) for the maintenance period, as determined by returned unused capsules'}], 'secondaryOutcomes': [{'measure': 'Change in microbiome composition after intervention', 'timeFrame': '180 days', 'description': 'Assessment of gut microbiome composition in pre- and post-randomization stool samples using bacterial culture and culture-independent (sequencing) assays.'}, {'measure': 'Number of biomarker samples collected, by sample type and timepoint', 'timeFrame': '30 days', 'description': 'Successful adherence to biomarker sample collection is defined as \\>80% of participants having samples suitable for analysis at 30 days post-intervention'}, {'measure': 'Concentration of potential biomarkers in pre- and post-randomization blood and urine samples', 'timeFrame': '180 days', 'description': 'Microbial-derived metabolites (short chain fatty acids and bile acids in blood, and 3-indoxyl sulfate in urine), markers of intestinal permeability (soluble CD14, LPS, LPS-binding protein, ZO-1, intestinal fatty acid protein), immune cell profiles (CD8 T lymphocytes, CD4 T lymphocytes, T regulatory cells, B lymphocytes, Th17 cells, Th1 cells).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbial consortia', 'Microbiome', 'Decolonization', 'Infection', 'Bacteremia', 'Antibiotic', 'Microbiota', 'Antibiotic resistance'], 'conditions': ['Gram-negative Bacteremia', 'Microbial Colonization', 'Antibiotic Resistant Infection']}, 'descriptionModule': {'briefSummary': 'ARO-DECAMP is a multi-centre, placebo-controlled, pilot and feasibility randomized controlled trial for the microbial consortium Microbial Ecosystem Therapeutic-2. Non-intensive care unit patients ≥ 18 years old diagnosed with a bloodstream infection and receiving treatment for an antibiotic resistant organism will be included. Participants will be randomized to receive either MET-2 or placebo for 10 days. Recruitment rate and study intervention adherence will be evaluated for feasibility. Participants will be followed for 180 days, and biological samples will be collected periodically for clinical, ecological, and biomarker outcomes.', 'detailedDescription': 'Reconstituting the perturbed microbiome is a novel therapeutic modality with the potential to decrease ARO colonization and infection and combat AMR without additional pressure for selection of further antimicrobial resistance. No trial has yet assessed the potential of a therapeutic microbial consortium for ARO decolonization and infection prevention after antibiotic treatment.\n\nThe investigational product, Microbial Ecosystem Therapeutic-2 (MET-2), is a defined microbial community derived from healthy donor stool. MET capsules are orally administered mixtures of bacterial strains cultured from the stool of a healthy donor. This study is designed to determine if a trial of administration of MET-2 after antibiotic treatment for bloodstream infections is feasible. Stool and plasma biomarkers to assess the effects of the intervention will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (≥18 years old) inpatient not admitted to the ICU or equivalent (step-up and step-down units are eligible)\n2. Positive blood culture with an ARO:\n\n * AmpC beta-lactamase producing species: Enterobacter cloacae, Citrobacter spp., Klebsiella aerogenes, Serratia spp., Morganella morganii, Hafnia alvei OR\n * ESBL-producing gram-negative bacilli\n3. Currently receiving treatment for the bloodstream infection\n\nExclusion Criteria:\n\n1. Inability to swallow oral MET-2 or placebo capsule\n2. Recipient of small bowel transplant\n3. Inflammatory bowel disease, short bowel syndrome, diverting/non-diverting ileo/colostomy\n4. Use of \\>3 days over-the-counter or prescription probiotics (not including food additives) within 10 days of enrolment\n5. Receipt of fecal microbiota transplant (FMT) within 3 months of enrolment\n6. Absolute neutrophil count \\<0.5x109/L\n7. Death expected within 72 hours of enrolment\n8. Planned continuation of non-prophylaxis antimicrobial therapy active against the bloodstream isolate for \\>42 days\n9. Known pregnancy, planning to become pregnant during the study period, or breastfeeding\n10. Any other reason in view of the site investigator or treating team'}, 'identificationModule': {'nctId': 'NCT06214403', 'acronym': 'ARO-DECAMP', 'briefTitle': 'Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation (ARO-DECAMP): a Multi-centre, Randomized, Placebo-controlled Feasibility Pilot Trial', 'orgStudyIdInfo': {'id': '23-5419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MET-2', 'description': 'Participants randomized to the intervention will receive MET-2 daily for 10 days. MET-2 capsules are administered orally at 0.5 g per capsule, containing 3.1 x 10\\^5-10\\^11 colony forming units (CFU). An initial loading dose of 10 MET-2 capsules/day will be taken for 2 days (5 grams total). For the following 8 days, participants will take a maintenance dose of 3 MET-2 capsules/day (1.5 grams total).', 'interventionNames': ['Drug: MET-2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants randomized to the placebo will receive microcrystalline cellulose in a capsule, identical in appearance to MET-2 but not containing live bacteria. Participants will take the placebo in the same dosing schedule as the MET-2 arm: 10 capsules daily for 2 days, followed by 3 capsules daily for 8 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MET-2', 'type': 'DRUG', 'description': 'Microbial Ecosystem Therapeutics (MET) is a defined microbial community derived from healthy donor stool. MET capsules are orally administered mixtures of pure cultures of human-derived bacterial strains.', 'armGroupLabels': ['MET-2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Microcrystalline Cellulose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1L7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sinai Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Bryan Coburn, MD, PhD', 'role': 'CONTACT', 'email': 'bryan.coburn@uhn.ca', 'phone': '416-634-7457'}, {'name': 'Noelle Yee', 'role': 'CONTACT', 'email': 'noelle.yee@uhn.ca', 'phone': '416-302-5715'}], 'overallOfficials': [{'name': 'Bryan Coburn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}