Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-30 @ 10:24 AM
Study NCT ID:
NCT06805994
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 175}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric nasal microbiome diversity after parent-to-child NMT.', 'timeFrame': 'Day 2, 4, 7, 10, 14 days post-intervention', 'description': 'This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 's. aureus', 'staph'], 'conditions': ['Staphylococcal Aureus Infection', 'Microbial Colonization', 'Pediatric Infection', 'S. Aureus Colonization', 'Microbial Transplant']}, 'descriptionModule': {'briefSummary': 'This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment', 'detailedDescription': 'This parent-to-child NMT study will test the effect of an anterior nares, or nasal, microbiota transplant (NMT) on seeding, engraftment, and diversity of the neonatal microbiome following nasal decolonization for S. aureus. Infants admitted to the Johns Hopkins Neonatal Intensive Care Unit (NICU) will be screened and parents will be approached for enrollment in the study. After consent and baseline screening of parents and infants, eligible infants will undergo an NMT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '0 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Child:\n\nInclusion criteria\n\n1. Child has had a prior nasal surveillance culture grow S. aurues\n2. Child is \\<18 years of age\n3. Child completed treatment with intranasal mupirocin for S. aureus nasal colonization as part of routine clinical care two or more days before the planned transplant\n4. Child has anticipated hospital length of stay \\>3 days after completing intranasal mupirocin treatment\n5. Infant \\>25 weeks gestation unless \\>2 months chronological age\n\nExclusion criteria\n\n1. Child is a ward of the State\n2. Child with a diagnosis of immunodeficiency or antenatal suspicion for immunodeficiency (e.g., sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)\n3. Child cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)\n\nDonor:\n\nInclusion criteria\n\n1. Donor is able to provide informed consent\n2. Donor has a relationship with the child outside of the hospital setting (i.e., not an ICU caregiver)\n\nExclusion criteria\n\n1. Donor had positive COVID-19 test in prior 21 days\n2. Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)\n3. Donor has been in close contact with someone in the last 7 days who had a respiratory viral infection (e.g., cold, flu)\n4. Donor tests positive on baseline screening test for S. aureus nasal colonization.\n5. Donor tests positive on baseline screening test for a respiratory pathogen.\n6. Donor is not able to provide written informed consent\n7. Donor is not able to be present at the bedside at the time of intervention.\n8. Donor has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.\n9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire.\n10. Donor has smoked within the last month'}, 'identificationModule': {'nctId': 'NCT06805994', 'acronym': 'NMT Protocol 3', 'briefTitle': 'Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization', 'orgStudyIdInfo': {'id': 'IRB00480834'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single NMT', 'description': 'Swab parent nares then insert swab directly into child nares once.', 'interventionNames': ['Biological: Nasal Microbiota Transplant (NMT)']}, {'type': 'EXPERIMENTAL', 'label': 'Repeat NMT', 'description': 'Swab parents nares then insert swab directly into child nares multiple times.', 'interventionNames': ['Biological: Nasal Microbiota Transplant (NMT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Insert a sterile swab into child nares.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Nasal Microbiota Transplant (NMT)', 'type': 'BIOLOGICAL', 'description': 'nasal microbiota transplant', 'armGroupLabels': ['Repeat NMT', 'Single NMT']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo sterile swab', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Koontz, Research Manager', 'role': 'CONTACT', 'email': 'dkoontz1@jhmi.edu', 'phone': '443-287-9040'}, {'name': 'Aaron M Milstone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Danielle Koontz, Research Manager', 'role': 'CONTACT', 'email': 'dkoontz1@jhmi.edu', 'phone': '4432879040'}, {'name': 'Slade Decker, Senior Research Coordinator', 'role': 'CONTACT', 'email': 'sdecker9@jhmi.edu', 'phone': '4109550405'}], 'overallOfficials': [{'name': 'Aaron M Milstone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}