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New treatment option for Staphylococcal Aureus Infection
Official title Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
ClinicalTrials.gov ID: NCT06805994
What this study is testing
What is Nasal Microbiota Transplant (NMT)?
Nasal Microbiota Transplant (NMT) is an investigational medicine, being studied as a potential treatment for staphylococcal aureus infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Child:
- 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...
- Child has anticipated hospital length of stay \>3 days after completing intranasal mupirocin treatment
You likely can't join 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...
- 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
See the full eligibility criteria
- Child:
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.