drugset / Trial / NCT02901288
Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis
Phase 4
Unknown
3900 enrolled
Beijing Chest Hospital
Anhui Chest Hospital · collabBeijing Research Institute for Tuberculosis Control · collabCentre for Tuberculosis Control of Guangdong Province · collabChangchun Infectious Disease Hospital · collabChengdu Public Health Clinical Center · collabChest of Hospital of Xinjiang Uygur Autonomous Region of the PRC · collabChongqing Infectious Disease Medical Center · collabFirst Affiliated Hospital of Xinjiang Medical University · collabGuangxi Zhuang Autonomous Region Center for Disease Prevention and Control · collabHarbin Chest Hospital · collabHeilongjiang Province center for tuberculosis Control and Prevention · collabHubei Provincial Center for Disease Control and Prevention · collabHunan Institute For Tuberculosis Control · collabInfectious Disease Prevention Hospital in Heilongjiang Province · collabKaifeng Central Hospital · collabPulmonary Hospital of Lanzhou · collabShanghai Pulmonary Hospital, Shanghai, China · collabShenyang Chest Hospital · collabSixth People's Hospital of Nanyang City · collabTaiyuan Fourth People's Hospital · collabThe Fifth People's Hospital of Suzhou · collabThe Fourth People's Hospital of Ningxia Autonomous Region · collabThe Fourth People's Hospital of Qinghai Province · collabThe Infectious Disease Hospital of Wangkai Zaozhuang · collabThe Infectious Hospital of Hebi · collabThe Sixth People's Hospital of Nantong · collabThe Third People's Hospital of Kunming City · collabThe Third People's Hospital of Zhenjiang · collabThe Tuberculosis Prevention and Treatment Hospital of Shanxi Province · collabTianjin Haihe Hospital · collabTianjin centers for Disease Control and Prevention · collabTuberculosis Hospital in Jilin Province · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWuhan Institute for Tuberculosis Control · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate the safety and efficacy of two shortened regimens for newly diagnosed smear positive drug susceptible pulmonary tuberculosis in comparison to World Health Organization recommended standard 6-month regimen.
Timeline
- Start
- 2016-08
- Primary completion
- 2018-12
- Completion
- 2018-12
Publications
- Gao M, Gao J, Du J, Liu Y, Zhang Y, Ma L, Mi F, Li L, Tang S; Trial Team. Efficacy of ultra-short course chemotherapy for new smear positive drug susceptible pulmonary tuberculosis: study protocol of a multicenter randomized controlled clinical trial. BMC Infect Dis. 2017 Jun 19;17(1):435. doi: 10.1186/s12879-017-2505-7.
- Pease C, Hutton B, Yazdi F, Wolfe D, Hamel C, Quach P, Skidmore B, Moher D, Alvarez GG. Efficacy and completion rates of rifapentine and isoniazid (3HP) compared to other treatment regimens for latent tuberculosis infection: a systematic review with network meta-analyses. BMC Infect Dis. 2017 Apr 11;17(1):265. doi: 10.1186/s12879-017-2377-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ethambutol | Small molecule | 750 mg | Oral |
| Subject | Ethambutol | Small molecule | 1000 mg | Oral |
| Subject | Isoniazid | Small molecule | 300 mg | Oral |
| Subject | Levofloxacin | Small molecule | 600 mg | Oral |
| Subject | Levofloxacin | Small molecule | 800 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 30 mg/kg | Oral |
| Subject | Pyrazinamide | Small molecule | 1500 mg | Oral |
| Subject | Rifampin | Small molecule | 450 mg | Oral |
| Subject | Rifampin | Small molecule | 600 mg | Oral |