TRITON Study

Study Name

Paradoxical Tuberculosis Reactions in Patients Who Do Not Have HIV

Study Number

19-I-0133

Goal of Study

We are studying a condition called paradoxical reaction that some people get when they take treatment for tuberculosis (TB). Most people with 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 opposite effect is a paradoxical reaction. We do not understand how this reaction happens. It can be hard to tell whether worsening symptoms are caused by a paradoxical reaction or something else, such as if the treatment just is not working.

We are asking you to join this study so that we can watch your health closely while you take TB treatment. We will enroll some people who we think are having this reaction and some who are not. We will compare these two groups of people to look for differences. We hope to find out what causes this reaction and what happens after someone has it. This will help us learn how best to diagnose it early, prevent it, or treat it.

Study Design

A total of 20 individuals experiencing a paradoxical reaction are expected to participate in this study. Another 40 people on TB treatment not experiencing a paradoxical reaction will also participate.

This study will not help or benefit you. We hope that what we learn in this study will help others being treated for TB in the future. This study will not provide treatment for TB. If you do not want to be in this study, you should still continue with the TB treatment given by your regular healthcare provider. If you choose to join the study and are eligible, we will ask you to come to the NIH Clinical Center 3 times over the next 6 to 18 months, depending on your doctor's plan for your TB treatment. We may ask you to come in for more visits if your TB symptoms become worse or you have new symptoms. The last study visit will be about 3 months after you finish TB treatment. After that, you will be done with the study. Study procedures include blood draws, urine collection, sputum collection, optional plasma collection, and a PET/CT body scan. Volunteers will be compensated.

Eligibility Criteria

• You are at least 18 years old with a TB diagnosis
• You have started TB treatment medications
• You have a primary care physician
• You are HIV-negative
• You allow the NIH to store blood and tissue samples for future research
• If female, you are not pregnant or breast-feeding
• You are in the DC Metro area, and able to travel to the NIH in Bethesda, Maryland

Visit ClinicalTrials.gov for details.