Training Protocol on the Natural History of Tuberculosis

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio

Observacional

Fase

No aplica / no indicada

Rango de edad

2 años - 100 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

150 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

Background:

\- Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies.

Objectives:

\- To collect blood and other samples to study the natural history of tuberculosis.

Eligibility:

\- Individuals 2 years of age and older who have either active or latent tuberculosis.

Design:

• Latent TB patients: Participants will have a single study visit with a physical examination and medical history, and will provide blood samples for testing.
• Active TB patients: Participants will have an initial visit with a physical examination and medical history, and will provide blood samples for testing. Participants will also provide sputum samples if required, and may have an optional skin punch biopsy to collect a sample of skin tissue for study.
• Treatment for active TB will be provided as part of this protocol.
• Active TB participants may be asked to return for study visits every 1-2 months while receiving treatment.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

• INCLUSION CRITERIA:

FOR ALL PATIENTS

Patients may be included in this study who:

• Have or are suspected to have TB infection.
• Are aged 2 years or older.
• Have a primary care physician, infectious diseases physician, pulmonologist, or TB specialist outside of the NIH who can provide care of his or her TB infection outside the NIH, provide directly observed therapy (DOT) if necessary, and monitor for side effects and toxicity of TB medications.
• Are willing to consent to storage of specimens for future research.
• Able to provide informed consent for themselves or, if they lack the capacity to provide informed consent, have an appropriate Legally Authorized Representative (LAR; the study team will comply with NIH Human Research Protection Program \[HRPP\] Policy 403).

FOR PATIENTS WITH LATENT TB

In addition to the above-described inclusion criteria for all patients, patients may be included in the Latent TB part of this protocol who:

-Have documented evidence of a positive purified protein derivative (PPD) skin test or Interferon-gamma Release Assays (IGRA) test meeting American Thoracic Society (ATS)/CDC guidelines for latent TB; conversion can have occurred at any time.

FOR PATIENTS WITH ACTIVE TB

In addition to the above-described inclusion criteria for all patients, patients may be included in the Active TB part of this protocol who:

• Have active TB of any drug susceptibility pattern and any site of infection as determined by smear, culture, or biopsy.
• Have appropriately documented clinically suspicious active TB without definitive microbiology confirmation.

EXCLUSION CRITERIA:

Patients will be excluded from this study who:

• Are incarcerated.
• Have been ordered by a court to take TB medications.
• Are unwilling or unable to comply with prescribed therapy.
• Are pregnant.

EXCLUSION OF SPECIFIC POPULATIONS

Children: Children under the age of 2 are not eligible to enroll. The addition of the very young will not provide enough additional insights to justify the risk to this specific population.

Pregnant women: Pregnant women are not eligible for participation in this protocol because the study objectives can be achieved without the enrollment of this population. Enrolled participants who become pregnant during the study will be withdrawn.

Población del estudio

Patients will be referred by their physicians for study participation. In many cases, participants will be referred by physicians at their local health department tuberculosis clinics (where they often receive DOT for TB treatment). Family members may be recruited through requests made by the index case that family members contact study personnel for participation. A patient can be referred at any time point while he or she is receiving active treatment for tuberculosis. Male and female patients will be accepted without preference. Patients age 2 and older are eligible; however, severe infections may require highly specialized pediatric teams and institutions. Some referrals of pediatric cases will not be able to be handled appropriately at the NIH and may be deemed ineligible for admission, as determined by the Principal Investigator (PI). NIH employees and members of their immediate families may participate in this protocol.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No informado

Enmascaramiento

No informado

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Equipo y fechas

Patrocinador principal

National Institute of Allergy and Infectious Diseases (NIAID)

Inicio del estudio

30 jun 2011 Real

Finalización primaria

No informado

Finalización del estudio

No informado

Primera publicación

30 sept 2010 Estimado

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio