RecruitingNCT04052022

Paradoxical Tuberculosis Reactions in Patients Without HIV Infection


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

140 participants

Start Date

Dec 20, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

Background: Most people with tuberculosis (TB) feel better after starting treatment. But for some people, the opposite happens. They may feel better at first, but then suddenly get worse. This is a paradoxical reaction. Researchers want to better understand what causes this reaction and what happens after someone has it. Objective: To learn about paradoxical reactions to TB treatment. Eligibility: Adults 18 and older diagnosed with confirmed or suspected TB and currently on treatment for at least 2 weeks, with or without signs/symptoms of a paradoxical inflammatory reaction. Design: Participants will be screened with a physical exam and medical history. They will give blood and urine samples. Eligible participants will visit either the NIH Clinical Center or the Mexico Clinic sites 3 times over 6 to 18 months. Each visit will take 7 hours to complete; visits may be scheduled over more than 1 day. Participants may have more visits if their TB symptoms change. Participants will give blood, urine, and sputum samples. They will have adverse event assessments. They will have 2 to 3 positron emission tomography/computed tomography (PET/CT) scans. PET/CT scans make pictures of the inside of the body. For this, participants will lie on a table that slides into a donut-shaped scanner. They will get a small amount of radioactive dye through an IV, which is a small plastic tube placed in a vein in the arm using a needle. Participants may have optional apheresis at the NIH site only. For this, blood is taken from a needle in one arm. White blood cells are separated from the rest of the blood. The rest of the blood is returned through a needle in the other arm.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study investigates a phenomenon called a paradoxical tuberculosis reaction — where a patient with TB seems to get worse (more inflammation, worsening symptoms) shortly after starting effective antibiotic treatment, even though the bacteria are being killed. Researchers want to understand why this happens, who is at risk, and how to manage it. **You may be eligible if...** - You are 18 or older with a confirmed or suspected tuberculosis (TB) diagnosis - You are currently on TB antibiotic treatment (for at least 2 weeks) or have completed treatment - You have developed new or worsening symptoms after initial improvement that suggest a paradoxical reaction (e.g., new lymph node swelling, worsening lung findings, or lab signs of inflammation) **You may NOT be eligible if...** - Your worsening is explained by a new infection or a different cause - You have HIV infection (this study focuses on HIV-negative patients) - You do not meet the clinical criteria for a paradoxical reaction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(2)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Mexican Emerging Infectious Diseases Clinical Research Network (LaRed)

Alcaldia Tlalpan, Mexico

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04052022


Related Trials