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Recruiting NCT06805994

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

Phase I Interventional Staphylococcal Aureus Infection Microbial Colonization Pediatric Infection S. Aureus Colonization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nasal Microbiota Transplant (NMT), Placebo.
Who it may be relevant to
Registry conditions: Staphylococcal Aureus Infection, Microbial Colonization, Pediatric Infection, S. Aureus Colonization. Basic parameters: 0 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization

Overview

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.

Interventions

  • Biological Nasal Microbiota Transplant (NMT)
    nasal microbiota transplant
  • Biological Placebo
    Placebo sterile swab

Primary outcome measures

  • Pediatric nasal microbiome diversity after parent-to-child NMT. [Time frame: Day 2, 4, 7, 10, 14 days post-intervention]

Eligibility criteria

Child:

Inclusion criteria

  • Child has had a prior nasal surveillance culture grow S. aurues
  • Child is <18 years of age
  • 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
  • Child has anticipated hospital length of stay >3 days after completing intranasal mupirocin treatment
  • Infant >25 weeks gestation unless >2 months chronological age

Exclusion criteria

  • Child is a ward of the State
  • Child with a diagnosis of immunodeficiency or antenatal suspicion for immunodeficiency (e.g., sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
  • Child cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)

Donor:

Inclusion criteria

  • Donor is able to provide informed consent
  • Donor has a relationship with the child outside of the hospital setting (i.e., not an ICU caregiver)

Exclusion criteria

  • Donor had positive COVID-19 test in prior 21 days
  • Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
  • Donor has been in close contact with someone in the last 7 days who had a respiratory viral infection (e.g., cold, flu)
  • Donor tests positive on baseline screening test for S. aureus nasal colonization.
  • Donor tests positive on baseline screening test for a respiratory pathogen.
  • Donor is not able to provide written informed consent
  • Donor is not able to be present at the bedside at the time of intervention.
  • Donor has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
  • Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire.
  • Donor has smoked within the last month

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Johns Hopkins University — Baltimore

Identifiers

NCT: NCT06805994 · IRB00480834

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗