Microbial Colonization, Microbial Transplant, Pediatric Infection, S. Aureus Colonization, Staphylococcal Aureus Infection
Conditions
Keywords
microbiome, s. aureus, staph
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.
Interventions
BIOLOGICALNasal Microbiota Transplant (NMT)
nasal microbiota transplant
BIOLOGICALPlacebo
Placebo sterile swab
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Child: Inclusion criteria 1. Child has had a prior nasal surveillance culture grow S. aurues 2. Child is \<18 years of age 3. 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 4. Child has anticipated hospital length of stay \>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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric nasal microbiome diversity after parent-to-child NMT. | Day 2, 4, 7, 10, 14 days post-intervention | This outcome will be determined by analysis of periodic surveillance swabs collected after intervention. |
Countries
United States
Contacts
CONTACTDanielle Koontz, Research Manager
CONTACTSlade Decker, Senior Research Coordinator
PRINCIPAL_INVESTIGATORAaron M Milstone, MD
Johns Hopkins University
Outcome results
None listed