Condition: Latent Tuberculosis · Sponsor: Centers for Disease Control and Prevention
This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI). This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care. The hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm). Participants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment. After completion of data collection, statistical analyses will be conducted to compare pr…
This description comes directly from the study's public registry record.
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| Denver Health and Hospital Authority | Denver, Colorado, United States | Recruiting |
| George Washington University | Washington D.C., District of Columbia, United States | Recruiting |
| Washington DC VA Medical Center | Washington D.C., District of Columbia, United States | Recruiting |
| New York Harbor Healthcare System | Manhattan, New York, United States | Recruiting |
| New York City Bureau of TB Control | New York, New York, United States | Recruiting |
| San Antonio VA | San Antonio, Texas, United States | Active Not Recruiting |
| Seattle King County Health Department | Seattle, Washington, United States | Recruiting |
| Liverpool Hospital | Sydney, Australia | Recruiting |
| Paramatta Chest | Sydney, Australia | Recruiting |
| Royal Prince Alfred Hospital | Sydney, Australia | Recruiting |
| National Referral University Hospital for Pneumo-physiology | Cotonou, Benin | Active Not Recruiting |
| Calgary TB Clinic | Calgary, Alberta, Canada | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03474029