Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Chest Hospital
• Collaborators: Anhui Chest Hospital; Beijing Research Institute for Tuberculosis Control; Centers for Disease Control and Prevention, China; Centre for Tuberculosis Control of Guangdong Province; Changchun Infectious Disease Hospital; Changsha Central Hospital; Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC; China Shenyang Chest Hospital; Chongqing Infectious Disease Medical Center; Dalian Tuberculosis Hospital; First Affiliated Hospital of Xinjiang Medical University; Fouzhou Pulmonary Hospital of Fujian; Guangxi Center for Disease Prevention and Control; Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control; Guiyang Public Health Clinical Center; Handan Infectious Disease Hospital; Harbin Chest Hospital; Hebei 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; Jiamusi City Tumour Hospital; Jiangxi Chest Hospital; Kaifeng Central Hospital; Kaifeng Pulmonary Disease Hospital; Mudanjiang City Hospital of Infectious Disease; Public Health Clinical Center of Chengdu; Pulmonary Hospital of Lanzhou; Qingdao Chest Hospital; Shanghai Pulmonary Hospital, Shanghai, China; Shenyang Chest Hospital; Shenzhen Third Peple's Hospital; 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 First Affiliated Hospital of Xiamen University; The First Affiliated Hospital of Xinxiang Medical University; The First Affiliated Hospital with Nanjing Medical University; The Fourth People's Hospital of Ningxia Autonomous Region; The Hospital Group of the First Affiliated Hospital of CQMU; The Infectious Disease Hospital of Wangkai Zaozhuang; The Infectious Hospital of Hebi; The Sixth People's Hospital of Nantong; The Sixth Peple's Hosptal of Zhengzhou; 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 Union Hospital, China; Xi'an Chest Hospital
• Treatments: Ethambutol; Isoniazid; Levofloxacin; Ofloxacin; Pyrazinamide; Rifampin

Criteria

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.