Tuberculosis, Pulmonary Clinical Trial
Official title:
Shortened Regimens for First Diagnosed Smear Positive Drug Susceptible Pulmonary Tuberculosis: a Randomised Controlled Non-inferiority Trial
Verified date | March 2017 |
Source | Beijing Chest Hospital |
Contact | Shenjie Tang, MD |
tangsj1106[@]sina.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 3900 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate). 2. Is aged 18-65 years. 3. Has twice positive acid-fast bacilli(AFB) sputum smear or positive sputum culture result, along with chest x-ray imaging consistent with active pulmonary tuberculosis. 4. Newly diagnosed cases receiving anti-TB treatment for less than one month 5. Urine Human Chorionic Gonadotropin(U-HCG) negative and must agree to use effective contraception during the trial period. 6. Has Alanine aminotransferase(ALT)and Total bilirubin(TBil) less than 2 times the upper limit of normal ; has Creatinine clearance rate (CrCI) more than 30ml/min; has Hemoglobin more than 7.0g/dL; has Platelet(PLT)more than 50 x10^9/L before study entry. Exclusion Criteria: 1. Concomitant severe cardiovascular, liver, kidney, nervous system, hematopoietic system and other diseases, or concomitant neoplastic diseases. Or extensive lesion with respiratory insufficiency. 2. Uncontrolled diabetes mellitus. 3. Concomitant mental disorders. 4. Is HIV positive. 5. Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study. 6. Is known to be pregnant or breast-feeding. 7. Is unable or unwilling to comply with the treatment, assessment, or follow-up schedule. 8. Is taking any medications contraindicated with the medicines in any trial regimen of the study. 9. Has a known allergy to any drug of treatment regimens. 10. Is currently taking part in another trial. 11. Has a QTc interval more than 480ms. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chest Hospital,Capital Meical University | Beijing | Beijing |
China | Beijing Research Institute for Tuberculosis Control | Beijing | Beijing |
China | Changchun Infectious Disease Hospital | Changchun | Jilin |
China | Hunan Institute For Tuberculosis Control | Changsha | Hunan |
China | Public Health Clinical Center of Chengdu | Chengdu | Sichuan |
China | Chongqing Infectious Disease Medical Center | Chongqing | Chongqing |
China | Centre for Tuberculosis Control of Guangdong Province | Guangzhou | Guangdong |
China | Infectious Disease Prevention Hospital in Heilongjiang Province | Ha'erbin | Heilongjiang |
China | Heilongjiang Province center for tuberculosis Control and Prevention | Haerbin | Heilongjiang |
China | Harbin Chest Hospital | Harbin | Heilongjiang |
China | The Infectious Hospital of Hebi | Hebi | Henan |
China | Anhui Chest Hospital | Hefei | Anhui |
China | Tuberculosis Hospital in Jilin Province | Jilin | Jilin |
China | Kaifeng Pulmonary Disease Hospital | Kaifeng | Henan |
China | The Third People's Hospital of Kunming City | Kunming | Yunnan |
China | Pulmonary Hospital of Lanzhou | Lanzhou | Gansu |
China | Guangxi Center for Disease Prevention and Control | Nanning | Guangxi |
China | The Sixth People's Hospital of Nantong | Nantong | Jiangsu |
China | Sixth People's Hospital of Nanyang City | Nanyang | Henan |
China | Shanghai Pulmonary Hospital | Shanghai | Shanghai |
China | China Shenyang Chest Hospital | Shenyang | Jilin |
China | HeBei Province Center for Disease Prevention and Control | Shijiazhuang | Hebei |
China | The Fifth People's Hospital of Suzhou | Suzhou | Jiangsu |
China | Taiyuan Fourth People's Hospital | Taiyuan | Shanxi |
China | The Infectious Disease Hospital of Wangkai Zaozhuang | Tengzhou | Shandong |
China | Tianjin centers for Disease Control and Prevention | Tianjin | Tianjin |
China | Tianjin Haihe Hospital | Tianjin | Tianjin |
China | Wuhan Institute For Tuberculosis Control | Wuhan | Hubei |
China | Wuhan medical treatment center | Wuhan | Hubei |
China | Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC | Wulumuqi | Xinjiang |
China | The Tuberculosis Prevention and Treatment Hospital of Shanxi Province | Xi'an | Shanxi |
China | The First Affiliated Hospital of Xinxiang Medical University | Xianxiang | Henan |
China | The 4th People's Hospital of Qinghai Province | Xining Shi | Qinghai |
China | The Fourth People's Hospital of Ningxia Autonomous Region | Yinchuan | Ningxia |
China | The Third People's Hospital of Zenjiang | Zhenjiang | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Beijing Chest Hospital | Anhui Chest Hospital, Beijing Research Institute for Tuberculosis Control, Centre for Tuberculosis Control of Guangdong Province, Changchun Infectious Disease Hospital, Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC, China Shenyang Chest Hospital, Chongqing Infectious Disease Medical Center, First Affiliated Hospital of Xinjiang Medical University, Guangxi Center for Disease Prevention and Control, Harbin Chest Hospital, Heilongjiang Province center for tuberculosis Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Hunan Institute For Tuberculosis Control, Infectious Disease Prevention Hospital in Heilongjiang Province, Kaifeng Pulmonary Disease Hospital, Public Health Clinical Center of Chengdu, Pulmonary Hospital of Lanzhou, Shanghai Pulmonary Hospital, Shanghai, China, Sixth People's Hospital of Nanyang City, Taiyuan Fourth People's Hospital, The 4th People's Hospital of Qinghai Province, The Fifth People's Hospital of Suzhou, The Fourth People's Hospital of Ningxia Autonomous Region, The Infectious Disease Hospital of Wangkai Zaozhuang, The Infectious Hospital of Hebi, The Sixth People's Hospital of Nantong, The Third People's Hospital of Kunming City, The Third People's Hospital of Zhenjiang, The Tuberculosis Prevention and Treatment Hospital of Shanxi Province, Tianjin centers for Disease Control and Prevention, Tianjin Haihe Hospital, Tuberculosis Hospital in Jilin Province, Wuhan Institute for Tuberculosis Control, Wuhan medical treatment center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percentage of participants with TB recurrence/relapse by 24 months after the end of treatment. | 24 months after treatment completion for all 3 groups | ||
Primary | Percentage of participants with treatment failure at either 4.5 months or 6 months after randomization. | 4.5 months after randomization for experimental group1 and 2; 6 months after randomization for control group | ||
Secondary | Treatment adverse reactions occuring | An average of 6 months for control group and 4.5 months for experimental group1 and 2 during treatment and 24 months after treatment completion. | ||
Secondary | Time to sputum smear or culture conversion within intensive phase . | An avergae of 2-3 months after randomization. | ||
Secondary | Sputum smear or culture conversion proportion at the treatment completion. | An average of 6 months for control group while 4.5 months for experimental group 1 and 2. | ||
Secondary | Radiological manifestation change of TB lesion or cavity. | An average of 6 months during treatment and 24 months after treatment completion. | ||
Secondary | Patiens adherence rate | An average of 6 months during treatment and 24 months after treatment completion. |
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