Treatment for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Healthy Subjects (HS)+3 More
Eligibility
18 - 65
All Sexes
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Study Summary

This study is evaluating whether a TB skin test can be used to test for TB exposure.

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Eligible Conditions

  • Healthy Subjects (HS)
  • Latent Tuberculosis Infection (LTBI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Healthy Subjects (HS). Measurement will happen over the course of 30 days.

30 days
location and longevity of immune cell activity in the pulmonary parenchyma and thoracic lymph nodes
pulmonary immune response to mycobacterial antigens

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

This trial requires 100 total participants across 0 different treatment group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 days for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults 18-64 years old will be recruited for the two groups (non-LTBI controls vs confirmed LTBI). The lower limit of this age range is based on the need for invasive bronchoscopic procedures and exposure to radiation, both of which carry more risk at younger ages. In addition, most adults present with post-primary or reactivation TB that most often occurs radiographically in the upper lobes of the lungs, often with cavitation. Conversely, children and rare adults with primary TB have non-cavitary disease in the lower lobes. The higher limit of this age range is based on the known property of immune senescence, i.e., the waning of the strength of immune responses with advancing age.
You are able to understand the nature and purpose of the study and are willing to sign a written informed consent document. show original
You are willing to comply with all study procedures and are available for the duration of the study. show original
You are a male or female aged 18 - 64 years of age. show original
No significant active medical problems. This would include but not limited to any cardiac disorder (e.g. arrhythmia, valvular disease), pulmonary disease (e.g. asthma requiring chronic medications, chronic bronchitis, emphysema, obstructive sleep apnea), kidney disease (e.g. nephritis, nephrosis), rheumatologic disorder (e.g. inflammatory arthritis), endocrine disorder (e.g. diabetes, thyroid disease), liver disease (e.g. hepatitis), gastrointestinal disorder (e.g. inflammatory bowel disease) or infectious disease (e.g. active tuberculosis).
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and agreement to use such a method during study participation

Patient Q&A Section

How many people get latent tuberculosis a year in the United States?

"Results from a recent paper estimates that during a 1-year period, 4.5% of all persons in the United States will be exposed to MTB and fall into the latent tuberculosis category. This is a significant amount of disease associated with LTBI." - Anonymous Online Contributor

Unverified Answer

What causes latent tuberculosis?

"The primary etiologic factor of LTB is tuberculin skin testing. L-TB with a negative TST is more likely to have a noninfectious cause than other diagnoses." - Anonymous Online Contributor

Unverified Answer

What are the signs of latent tuberculosis?

"Signs of latent tuberculosis can include loss of appetite, weight loss, and fever. All of these symptoms can occur at any point in the disease progression. It can be difficult to diagnose the disease if symptoms occur in people with many other underlying diseases. For those with very low- or no-tuberculin skin test, a medical screening [Chest radiograph (X-ray) examination] is useful to eliminate the possibility of latent tuberculosis. The X-ray exam should be repeated after a period of 10 years. In addition, the disease may also be characterized by a slow progression or a gradual development without any symptoms. [Cigarette smoke (smoking) can lower response to BCG." - Anonymous Online Contributor

Unverified Answer

What are common treatments for latent tuberculosis?

"Anti-tubercular drugs like isoniazid and rifampin used for latent tuberculosis treatment may be associated with side effects and toxicity to some of the patients such as those exposed to illicit drugs. In addition to standard drug regimen treatment, anti-mycobacterial drugs such as rifampicin, and antitubercular drugs like isoniazid, streptomycin, and rifabutin can be used as additive antitubercular medications to enhance drug efficacy for treating latent tuberculosis patients." - Anonymous Online Contributor

Unverified Answer

What is latent tuberculosis?

"The rate of LTBI increased in subjects of the study in an age-dependent manner from 0.4%, to 4.6% in those < 65 years of age. In the current study our results strongly support the recommendation for the implementation of preventive measures for LTBI in TB-susceptible subjects. Patients suffering from tuberculosis are encouraged to receive LTBI testing from their clinicians." - Anonymous Online Contributor

Unverified Answer

Can latent tuberculosis be cured?

"A cure rate for patients diagnosed with LTBI can be set at 15-90%, depending on the definition of cure. It will be hard to define LTBI-cured or LTBI-non-cured patients and cure rates may range from 40% to 90%, depending on the definition and the LTBI treatment regimens being used. The definition of cure may need to be more explicit, and it may be necessary to change the definition. A cure cannot be defined in terms of an individual patient's subjective experience." - Anonymous Online Contributor

Unverified Answer

What is the latest research for latent tuberculosis?

"The number of papers on this topic was extremely small and a full review would have a large amount of conflicting data, so this review will include what was found. There were a small number of reports of latent tuberculosis and some of these were short or did not describe well enough the way the disease should be treated. There were also a few papers on how to make treatment more effective and these made some excellent suggestions." - Anonymous Online Contributor

Unverified Answer

Does latent tuberculosis run in families?

"[The overall prevalence of LTBI in our study group was very high (70%), and in many family members>20% had abnormal results] (https://www.reactionsint.com/thread/1123/lung-tuberculosis-reactions-in-families,). More studies should be done to confirm these findings and to determine the potential relationship of these findings and the prevalence of TB in other regions of the world." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets latent tuberculosis?

"The number of individuals who tested positive for latent tuberculosis is likely an underestimate, since the prevalence may be higher than current estimates. Nevertheless, the number and proportion of LTBI positive results (defined by the WHO recommendations for TB diagnosis) increases with age. More research should be undertaken to estimate the actual LTBI prevalence in high prevalence situations." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"There have not been other controlled trials concerning a combination that contains the anti-Mycobacterium tuberculosis drugs rifapentine and pyrazinamide. To date, only studies of these agents alone have been undertaken. In most of these studies, the response to the drugs is good, but treatment is more effective when implemented to treat latent tuberculosis. These studies in combination are important first steps in the creation of effective and safe tuberculosis treatment." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating latent tuberculosis?

"Current discoveries in the treatment of tuberculosis, with or without drug-resistance, have not yet resulted in an acceptable, useful treatment regimen for curing or halting tuberculosis. More research must be done before [a treatment (drug-sensitive) regimen could] be accepted by the medical community as the one most likely to succeed. In spite of this, the recent advances in research in latent infections, including those related to tuberculosis, are encouraging. There is some evidence that a combination of antibiotics, including rifampin and dapsone (a combination of drugs used to treat tuberculosis) may prove effective in those with latent tuberculosis." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for latent tuberculosis?

"The authors concluded that "a randomized clinical trial" is not the appropriate evaluation for patients with latent TB because it focuses on a single trial design and does not necessarily guarantee representative treatment groups with and without LTBI." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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