Actively Recruiting
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-30
140
Participants Needed
2
Research Sites
488 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with confirmed or suspected tuberculosis
- Currently on anti-tuberculosis treatment for at least 2 weeks or have completed treatment
- For paradoxical reaction group: at least 2 signs or symptoms of a paradoxical inflammatory reaction such as return of TB symptoms after initial improvement, new inflammatory findings on exam, worsening imaging, laboratory evidence of inflammation, or worsened organ function
- Symptoms or signs not explained by infection, treatment side effects, drug resistance, or other conditions except paradoxical reaction
- Willing to allow storage of blood or tissue samples for future research
- Able to understand study requirements and provide informed consent
- Has a primary care physician and is followed by local Department of Health for TB or plans to arrange this
- For control group: presenting 2 to 4 months after starting treatment to match timing of paradoxical reactions
You will not qualify if you...
- HIV infection
- Pregnant or breastfeeding
- Uncontrolled psychiatric disease, substance use, or conduct unsuitable for research
- Active malignancy requiring treatment such as radiation, chemotherapy, or immunotherapy
- Debilitating or chronic conditions limiting study participation
- Emergent or urgent clinical conditions needing immediate treatment not related to TB, requiring transfer to emergency care
AI-Screening
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Trial Site Locations
Total: 2 locations
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
Mexican Emerging Infectious Diseases Clinical Research Network (LaRed)
Alcaldia Tlalpan, Mexico, 14050
Actively Recruiting
Research Team
M
Mary E McLaughlin, R.N.
CONTACT
M
Maura M Manion, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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