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NCT04052022 · ClinicalTrials.gov registry record
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
A clinical trial of Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 140
- Enrollment target
- 2
- Study locations
NCT04052022: Recruiting study of Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04052022 is a study of Tuberculosis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 140 participants, below the 930-participant average among 29 other Tuberculosis trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04052022, a study of Tuberculosis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 140 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Characterize immunologic and radiographic responses of TB patients with suspected paradoxical reactions.
Conditions Studied
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Other
- Mexican Emerging Infectious Diseases Clinical Research Network (LaRed) - Alcaldia Tlalpan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2029-04-30 |
What NCT04052022 shows while recruiting
NCT04052022 is an observational study that tracks outcomes without assigning an intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 930-participant average among 29 other Tuberculosis trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Tuberculosis appearing as the primary indexed condition, and to 0 interventions.
NCT04052022 reports a single indexed study location in Maryland, Other.
Frequently Asked Questions
What is clinical trial NCT04052022 about?
NCT04052022 is a clinical study titled "Paradoxical Tuberculosis Reactions in Patients Without HIV Infection". 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 happen...
What is the current status of trial NCT04052022?
This trial is currently recruiting. The enrollment target is 140 participants. The study started on 2019-12-20. Estimated completion is 2029-04-30.
What conditions does trial NCT04052022 study?
This clinical trial studies the following conditions: Tuberculosis.
Who is sponsoring clinical trial NCT04052022?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04052022 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tuberculosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04052022's enrollment target sits among peer trials
140 14th of 29 higher than 16 of 29 other Tuberculosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tuberculosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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