Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention (NCT02430259) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention
China566 participantsStarted 2015-03
Plain-language summary
Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. For preventive therapy, the three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) are now recommended by WHO for its non-inferiority, safety and convenience compared with 6\~9 months regimen of daily isoniazid monotherapy or 3\~4 months daily rifampicin monotherapy. And the treatment completion rate is higher compared with daily regimen. However, relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000. And the provision of chemoprophylaxis is not recommended in China currently.
Silicosis is a high risk factor of Mycobacterium tuberculosis infection. This is an open-label, randomized, Phase III clinical trial to evaluate the effectiveness and tolerability of the 3RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals with Silica exposure or diagnosed with silicosis;
* Age between 18 to 65 years;
* Willing to provide signed informed consent, or parental consent and participant assent.
Exclusion Criteria:
* Clinical or culture confirmed active TB;
* A history of treatment for \> 14 consecutive days with a rifamycin or \> 30 consecutive days with INH during the previous 2 years;
* A documented history of a completing an adequate course of treatment for active TB or latent TB infection;
* Allergy to Isoniazid, Rifampin, or Rifapentine;
* Human immunodeficiency virus (HIV) infection;
* History of hepatitis B/C infection or liver cirrhosis;
* Serum Aspartic transaminase (AST) or alanine transaminase (ALT) \> 2x upper limit of normal or total bilirubin \>2.5 mg/dL;
* Receiving immunosuppressants or biological agents;
* Life expectancy \<3 years;
* Mental disorder;
* Participated in other clinical trials in recent three months;
* Other conditions that investigates consider not suitable for participate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants