Recruiting

Observational Study

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT06479837

Conditions

Staphylococcal Infections

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background:

Staphylococcus aureus (S.aureus) are bacteria that can make people sick. Sometimes, an S. aureus infection can develop inside the spine; these infections can lead to paralysis and death. Researchers do not know how S. aureus interacts with a person s cells to cause infections in the spine.

Objective:

To learn how S. aureus interacts with cells in the body using tissues from tonsils discarded after standard surgery to remove them.

Eligibility:

People aged 2 years and older who are scheduled to have their tonsils removed.

Design:

Researchers will select participants for the study based on review of their existing medical records, including results of blood tests; any imaging scans, including x-rays; and reports about tissue specimens.

Participants will answer questionnaires about their health and past infections. They can do this online or on paper.

Participants will collect a nasal swab 1 week before their surgery. They will be given a tool that looks like a long cotton swab. They will twirl it around inside their nose. The swab will pick up cells and fluids that will be used for research.

After their surgery, the participant s surgeon will save samples of tonsil tissue. The surgeon will send these tissue samples and the nasal swab to researchers at the NIH.

These tissues and the swab will be used in studies to help researchers understand how S. aureus interacts with cells in the body. They hope these studies will help them find better ways to treat S. aureus infections.

Conditions

Staphylococcal Infections

Study ID

NCT06479837

Start date

Sep 14, 2026

Status verified date

Dec 2, 2025

Completion date

Dec 1, 2044

Anticipated

Primary completion date

Dec 1, 2043

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Tonsillectomy Patients

Patients undergoing tonsillectomy as part of their clinical care

Primary outcome measure

  • Immune cell composition [ Time Frame: At time of collection ]
  • Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity [ Time Frame: At time of collection ]
  • Cytokine levels [ Time Frame: At time of collection ]
  • Activation-induced cytidine deaminase (AID) levels [ Time Frame: At time of collection ]
  • Single-cell inference of class switch recombination (sciCSR) [ Time Frame: At time of collection ]

Central Contacts and Locations

Central contacts

Locations

National Institute of Allergy and Infectious Diseases (NIAID)

Recruiting

Bethesda, Maryland, United States, 20892

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 9, 2026

Last verified

Dec 2, 2025

Keywords

  • Organoid
  • Staphylococcus
  • Host-pathogen Interactions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-09.