Clinical trial NCT06805994: Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
Official title: Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Staphylococcal Aureus Infection
Microbial Colonization
Pediatric Infection
S. Aureus Colonization
Microbial Transplant
Keywords: microbiome
s. aureus
staph
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 175
Sex: ALL
Minimum age (years): 0
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: Neonatal nasal microbiome diversity after parent-to-child NMT.
timeFrame: Day 2, 4, 7, 10, 14 days post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Aaron M Milstone, MD
role: PRINCIPAL_INVESTIGATOR
References: