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Protocol Details

Modeling Host-Pathogen Interaction Using Lymphoid Organoids

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

002062-I

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Adults who are or may become unable to consent;
Neonates;
Pregnant Women

Keywords

Organoid;
Staphylococcus;
Host-pathogen Interactions

Recruitment Keyword(s)

None

Condition(s)

Staphylococcal Infections

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Eligibility

INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

-Aged >=2 years.

-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 years).

-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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Michael Otto, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Rocky Mountain Labs, Room 5206
903 South 4th St
Hamilton, MT
(406) 363-9394
mo112y@nih.gov

Katherine Le, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 4-1479
10 Center Drive
Bethesda, Maryland 20892
(301) 761-7166
katherine.le@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT06479837

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