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Recruiting
NCT06805994
Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
Conditions: Staphylococcal Aureus Infection, Microbial Colonization, Pediatric Infection, S. Aureus Colonization, Microbial Transplant
Sex: All
Ages: 0 Years – 60 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 175
Sponsor: Johns Hopkins University
Location: Johns Hopkins University Baltimore Maryland
Summary
This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
Eligibility Criteria
Child:
Inclusion criteria
1. Child has had a prior nasal surveillance culture grow S. aurues
2. Child is \3 days after completing intranasal mupirocin treatment
5. Infant \>25 weeks gestation unless \>2 months chronological age
Exclusion criteria
1. Child is a ward of the State
2. Child with a diagnosis of immunodeficiency or antenatal suspicion for immunodeficiency (e.g., sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
3. Child cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
Donor:
Inclusion criteria
1. Donor is able to provide informed consent
2. Donor has a relationship with the child outside of the hospital setting (i.e., not an ICU caregiver)
Exclusion criteria
1. Donor had positive COVID-19 test in prior 21 days
2. Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
3. Donor has been in close contact with someone in the last 7 days who had a respiratory viral infection (e.g., cold, flu)
4. Donor tests positive on baseline screening test for S. aureus nasal colonization.
5. Donor tests positive on baseline screening test for a respiratory pathogen.
6. Donor is not able to provide written informed consent
7. Donor is not able to be present at the bedside at the time of intervention.
8. Donor has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire.
10. Donor has smoked within the last month
Source: ClinicalTrials.gov (NCT06805994). StuddyBuddy aggregates publicly available trial information.