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

NCT06805994 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB00480834
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

microbiome; s. aureus; staph

Outcome Measures

Primary Outcomes (1)

• Pediatric nasal microbiome diversity after parent-to-child NMT.

  This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.

  Day 2, 4, 7, 10, 14 days post-intervention

Study Arms (3)

Single NMT

EXPERIMENTAL

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

Biological: Nasal Microbiota Transplant (NMT)

Repeat NMT

EXPERIMENTAL

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

Biological: Nasal Microbiota Transplant (NMT)

Placebo

PLACEBO COMPARATOR

Insert a sterile swab into child nares.

Biological: Placebo

Interventions

Nasal Microbiota Transplant (NMT) BIOLOGICAL

nasal microbiota transplant

Repeat NMT; Single NMT

Placebo BIOLOGICAL

Placebo sterile swab

Placebo

Eligibility Criteria

• Age: 0 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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)
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Communicable Diseases; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Aaron M Milstone, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Koontz, Research Manager

CONTACT

4432879040; dkoontz1@jhmi.edu

Slade Decker, Senior Research Coordinator

CONTACT

4109550405; sdecker9@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)