No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 100
Sex
Any
Study type
Observational
Participants needed
150 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for
This trial is looking for people aged 2 and older who have tuberculosis, either active or latent. Participants will provide blood samples and may receive treatment for active tuberculosis.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 2 years old.
I have or am suspected to have tuberculosis.
I have a doctor who can manage my tuberculosis outside of this study.
I am willing to allow my samples to be stored for future research.
I can give informed consent or have someone to consent for me if I can't.
You may not be able to join if
I am currently in jail.
I have been forced by a court to take tuberculosis medications.
I cannot follow the prescribed therapy.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 tuberculo…
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....
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
* 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 …
* 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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.