2 for Latent Tuberculosis Infection

National Institutes of Health Clinical Center, Bethesda, MD
Targeting 2 different conditionsTuberculin Purified Protein DerivativePhase < 1RecruitingLed by Kevin P Fennelly, M.D.Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Study Summary

This trial is testing how the cells within the lung react when exposed to PPD, in order to better understand tuberculosis.

Eligible Conditions
  • Latent Tuberculosis Infection
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
pulmonary immune response to mycobacterial antigens
Secondary outcome measures
location and longevity of immune cell activity in the pulmonary parenchyma and thoracic lymph nodes

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
TST- IGRA-
Group II: 1Experimental Treatment1 Intervention
TST+ IGRA+
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tuberculin purified protein derivative
FDA approved

Find a site

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,731 Previous Clinical Trials
47,182,915 Total Patients Enrolled
Kevin P Fennelly, M.D.Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
900 Total Patients Enrolled
Ifeanyichukwu U Anidi, M.D.Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
550 Total Patients Enrolled

Media Library

2 Clinical Trial Eligibility Overview. Trial Name: NCT05027958 — Phase < 1
Latent Tuberculosis Infection Research Study Groups: 2, 1
Latent Tuberculosis Infection Clinical Trial 2023: 2 Highlights & Side Effects. Trial Name: NCT05027958 — Phase < 1
2 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027958 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research has been conducted to evaluate the efficacy of this treatment?

"Currently, 1 clinical trial is underway to analyze the efficacy of this treatment modality and none are in their final stages. The bulk of these studies are concentrated near Bethesda, Maryland although there is one other site conducting relevant research."

Answered by AI

Could you tell me the upper limit for participant enrollment in this clinical trial?

"Affirmative. According to the details available on clinicaltrials.gov, this experiment is looking for enrollees as of November 16th 2022 - almost 6 months after its initial posting on May 3rd 2022. The study needs a total of 100 patients from one site."

Answered by AI

Am I able to enroll in this research endeavor?

"This clinical trial is seeking 100 healthy individuals aged 18 to 64. To qualify, patients must understand the risks and sign a consent form; they cannot have any existing medical conditions or be of reproductive age without using effective contraception methods. In addition, due to radiation exposure from bronchoscopic procedures being more dangerous for younger people, as well as elder's weakened immune responses making them less likely to respond positively to treatment, this specific age range was chosen for safety reasons."

Answered by AI

Does this clinical experiment accept elderly participants?

"According to the criteria, participants must be between 18 and 64 years of age. For those younger than 18, there are 100 medical studies available; whereas patients older than 65 may access 507 clinical trials."

Answered by AI

Are there opportunities for individuals to participate in this trial at the present time?

"Affirmative. Clinicaltrials.gov's information shows that this medical trial, initially posted on May 3rd 2022, is currently looking for volunteers to participate in the study. One hundred participants must be recruited from one site only."

Answered by AI
~60 spots leftby Jan 2026