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PPD Challenge for Tuberculosis

Q: 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, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a> although there is one other site conducting relevant research.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Phase < 1

Recruiting

Led By Kevin P Fennelly, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Male or female, aged 18 - 64 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

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

Who is the study for?

Adults aged 18-64, either exposed to TB without active disease or never exposed. Must be healthy with no significant medical issues like heart, lung, kidney diseases, etc., and agree to use effective contraception if of reproductive potential. Can't join if they need oxygen at rest, have HIV, poor tolerance for bronchoscopy, immunosuppressive conditions or medications usage in the last 6 months including steroids.Check my eligibility

What is being tested?

The trial is testing how lung cells respond to Tuberculin Purified Protein Derivative (PPD) when it's directly applied into the lungs via bronchoscopy instead of under the skin. Participants will undergo three bronchoscopies and FDG PET-CT scans over about a month with up to eight clinic visits.See study design

What are the potential side effects?

Potential side effects may include discomfort from the bronchoscopy procedure such as sore throat or coughing; reactions at PPD application site; allergic responses to substances used during procedures like Lidocaine or Midazolam; and exposure risks associated with radioactive substance injection for imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use effective birth control during the study.

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I am between 18 and 64 years old.

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I do not have any major ongoing health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

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

N/A

~870

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor

3,838 Previous Clinical Trials

47,851,554 Total Patients Enrolled

Kevin P Fennelly, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

1 Previous Clinical Trials

900 Total Patients Enrolled

Ifeanyichukwu U Anidi, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

1 Previous Clinical Trials

550 Total Patients Enrolled

Media Library

1 Clinical Trial Eligibility Overview. Trial Name: NCT05027958 — Phase < 1

Latent Tuberculosis Infection Research Study Groups: 1, 2

Latent Tuberculosis Infection Clinical Trial 2023: 1 Highlights & Side Effects. Trial Name: NCT05027958 — Phase < 1

1 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

Recent research and studies

clinicaltrials.govStudy

Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung

2022. "Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05027958.

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