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NCT06805994 | NOT YET RECRUITING | Staphylococcal Aureus Infection

Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
Sponsor:

Johns Hopkins University

Brief Summary:

This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment

Condition or disease

Staphylococcal Aureus Infection

Microbial Colonization

Pediatric Infection

S. Aureus Colonization

Microbial Transplant

Intervention/treatment

Nasal Microbiota Transplant (NMT)

Placebo

Phase

PHASE1

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 175 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2027-01-01
Estimated Study Completion Date : 2027-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Infant
  • * Inclusion criteria
  • 1. Infant has had a prior nasal surveillance culture grow S. aurues
  • 2. Infant being treated with intranasal mupirocin for S. aureus nasal colonization as part of routine clinical care
  • 3. Infant has anticipated hospital length of stay \>3 days after completing intranasal mupirocin treatment
  • 4. Infant \>25 weeks gestation
  • 5. At least one donor not colonized with S. aureus or another respiratory pathogen (as determined by baseline screening)
  • * Exclusion criteria
  • 1. Infant is a ward of the State
  • 2. Infant with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
  • 3. Infant cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
  • Parent/adult provider
    • * Inclusion criteria
    • 1. Donor is able to provide informed consent
    • * 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
Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment

Location Details

NCT06805994

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How to Participate

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Locations

Not yet recruiting

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21287