Tuberculosis Trial, Recruiting NCT04052022 Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Condition: Tuberculosis
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Tuberculosis Trial, Recruiting

NCT04052022
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people experiencing a possible paradoxical reaction (worsening symptoms during or after TB treatment):

  • You are 18 years of age or older
  • You have been diagnosed with TB (confirmed by a lab test or suspected based on symptoms/tissue examination) and have been on TB treatment for at least 2 weeks, or have already finished treatment, AND you are showing signs of a paradoxical reaction — meaning your condition seemed to improve at first but then got worse again in at least 2 ways (such as returning TB symptoms, new swollen glands or lung changes, worsening scan results, abnormal blood test results showing inflammation, or worsening organ function)
  • Your worsening symptoms cannot be explained by a new infection, a known infection getting worse, side effects from TB medication, drug-resistant TB, or any other cause besides a paradoxical reaction
  • You are willing to allow blood or tissue samples to be stored for future research
  • You are able to understand the study requirements and sign a consent form
  • You have a regular doctor and are being monitored by your local health department for your TB (or are willing to arrange this after joining the study)

For people in the comparison group (people on TB treatment without a paradoxical reaction):

  • You are 18 years of age or older
  • You have been diagnosed with TB (confirmed by a lab test or suspected based on symptoms/tissue examination)
  • You are presenting 2 to 4 months after starting TB treatment
  • You are willing to allow blood or tissue samples to be stored for future research
  • You are able to understand the study requirements and sign a consent form
  • You have a regular doctor and are being monitored by your local health department for your TB (or are willing to arrange this after joining the study)

Who may not be able to join:

  • You are living with HIV (you may be eligible for a separate related study — confirm with trial site)
  • You are currently pregnant or breastfeeding
  • You have a psychiatric condition, substance use issue, or behavioural concern that is not well controlled and could affect your ability to participate in a research study
  • You have a cancer that requires treatment now or in the near future, such as radiation, chemotherapy, or immunotherapy
  • You have a long-term or serious health condition that would make it difficult for you to take part in the study
  • You have an urgent or emergency medical condition (unrelated to TB) that needs immediate treatment — though you may be able to re-apply once your condition has been stabilised (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Maura M Manion, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Phone: (301) 435-8001

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
20 December 2019
Est. completion
30 April 2029

Where this trial is recruiting

🇲🇽 Mexico 🇺🇸 United States

Primary endpoints

Immunologic and radiographic responses of TB patients with suspected paradoxical reactions.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov