Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment (NMT Protocol 3)

Johns Hopkins University

Status and phase: Enrolling; Phase 1

Conditions: Microbial Colonization; S. Aureus Colonization; Microbial Transplant; Staphylococcal Aureus Infection; Pediatric Infection

Treatments: Biological: Nasal Microbiota Transplant (NMT); Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06805994

IRB00480834

Details and patient eligibility

About

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

Full 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.

Enrollment: 175 estimated patients

Sex: All

Ages: Under 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

175 participants in 3 patient groups, including a placebo group

Single NMT

Experimental group

Description:

Swab parent nares then insert swab directly into child nares once.

Treatment:

Biological: Nasal Microbiota Transplant (NMT)

Repeat NMT

Experimental group

Description:

Swab parents nares then insert swab directly into child nares multiple times.

Treatment:

Biological: Nasal Microbiota Transplant (NMT)

Placebo

Placebo Comparator group

Description:

Insert a sterile swab into child nares.

Treatment:

Biological: Placebo