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

Launched by JOHNS HOPKINS UNIVERSITY · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a treatment called NMT (Nasal Microbiome Therapy) can help restore the diversity of bacteria in the noses of infants after they have been treated with mupirocin, a medication used to eliminate Staphylococcus aureus (a type of bacteria) that can cause infections. The goal is to see if NMT can improve the nasal microbiome, which is important for healthy immune function.

To participate in this trial, infants must have previously tested positive for Staphylococcus aureus and be undergoing mupirocin treatment, with an expected hospital stay of more than three days afterward. Infants must be over 25 weeks gestation and have a donor (like a parent) who is not carrying Staphylococcus aureus or other harmful germs. Participants can expect to receive NMT after their mupirocin treatment, and the study team will monitor their progress. This trial is not yet recruiting participants, so it’s a good idea to keep an eye out for updates if you think you might qualify.

Gender

ALL

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