Understanding how Staphylococcus aureus interacts with human cells using tonsil tissues
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
This study is testing how Staphylococcus aureus affects human cells using tonsil tissues from people having their tonsils removed to learn more about immune responses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 2 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 2 sites (Bethesda, Maryland and 1 other locations) |
| Trial ID | NCT06479837 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the interactions between Staphylococcus aureus and human cells by utilizing tonsil tissues that are typically discarded after tonsillectomy. Researchers will develop lymphoid organoid models to evaluate immune responses to the Chemotaxis Inhibitory Protein of S. aureus (CHIPS). Participants aged 2 years and older, who are scheduled for tonsil removal, will provide nasal swabs and answer health questionnaires. The study will analyze immune cell composition, antibody levels, and cytokine levels to better understand host-pathogen interactions.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 2 years and older who are undergoing tonsillectomy.
Not a fit: Patients with active infections, immunosuppressive conditions, or those currently taking immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and treatment of Staphylococcal infections, particularly those affecting the spine.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding host-pathogen interactions using organoid models.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all of the following criteria: * Aged \>=2 yrs. * Undergoing tonsillectomy as part of their clinical care. * Able to provide informed consent (for ages \>=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \<18 yrs). * Willing to allow samples and data to be stored and shared for future secondary research. * Willing to allow future genetic testing on their biospecimens. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Active infection. * Active tonsilitis. * Pregnant. * Diagnosed with an immunosuppressive condition or currently taking immunosuppressive medications. * Current or past intravenous drug use. * Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study
Where this trial is running
Bethesda, Maryland and 1 other locations
- National Institute of Allergy and Infectious Diseases (NIAID) — Bethesda, Maryland, United States (Recruiting)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Michael Otto, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Katherine Le, M.D.
- Email: katherine.le@nih.gov
- Phone: (301) 761-7166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.