Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis
NCT ID: NCT02901288
Last Updated: 2017-03-20
Study Results
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Basic Information
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UNKNOWN
PHASE4
3900 participants
INTERVENTIONAL
2016-08-31
2018-12-31
Brief Summary
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Detailed Description
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2. Population: patients with newly diagnosed drug-susceptible pulmonary TB who fulfill the inclusion and exclusion criteria.
3. Investigational regimens:
Experimental group 1 regimen consists of levofloxacin, isoniazid , rifampicin,ethambutol and pyrazinamide for 4.5 months.
Experimental group 2 regimen consists of isoniazid, rifampicin, ethambutol and pyrazinamide for 4.5 months.
The control group is WHO recommended regimen conmposed of isoniazid , rifampicin, ethambutol and pyrazinamide for 2 months, followed by isoniazid , rifampicin for 4 months.
Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg(less than 50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less than 50kg,once daily) or 1000mg (more than 50kg,once daily), levofloxacin 600mg(less than 50kg,given once daily) or 800mg(more than 50kg,once daily)..
4. Trial objectives: to evaluate that shortened regimens is not inferior to standard treatment in terms of efficacy and safety for new smear positive pulmonary TB patients.
5. Primary and Secondary outcome measures:
The primary efficacy outcome measures include (a)the percentage of participants with TB recurrence/relapse by 24 months after the end of treatment;(b) percentage of participants with treatment failure at either 4.5 months or 6 months after randomization. (a) Time to sputum smear or culture conversion within intensive phase.(b) Sputum smear conversion proportion at the treatment completion. (c) Number of adverse drug reaction occurring during treatment or follow-up period. (d) Radiological manifestation change of TB lesion or cavity.(e) Patients adherence rate.
6. Sample Size:
Approximately 3900 participants will be enrolled and randomized with 1:1:1 ratio into either Experimental group1, Experimental group2 or control group.
7. Blinding:
The study is an open-label study.
8. Assessment and follow-up:
All patients will be followed by to 2 years after completion of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group1
The experimental group1 all oral regimen is consisted of isoniazid,rifampin, pyrazinamide, ethambutol and levofloxacin for 4.5 months.
Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg((less than 50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less than 50kg,once daily) or 1000mg (more than 50kg,once daily), levofloxacin 600mg(less than 50kg,given once daily) or 800mg(more than 50kg,once daily).
Isoniazid
Isoniazid is a widely used anti-tuberculosis medication. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique components of mycobacterial cell wall.
Rifampicin
Rifampicin is a widely used anti-tuberculosis medication.
Pyrazinamide
Pyrazinamide is a commonly used medication for tuberculosis, with bactericidal effect against intracellular mycobacterium tuberculosis.
Ethambutol
Ethambutol is a widely used medicine in anti-TB regimens with bacteriostatic effect against M. tb.
Levofloxacin
Levofloxacin is a commonly used antimicrobial for TB and other infections, which acts on the DNA-DNA-gyrase complex and topoisomerase IV. It is the S (-) enantiomer of the racemic active substance ofloxacin.
experimental group2
The experimental group2 all oral regimen consisted of isoniazid,rifampin, pyrazinamide, and ethambutol for 4.5 months. The dosage of isoniazid,rifampin, pyrazinamide, and ethambutol is as same as that of control regimen.
Isoniazid
Isoniazid is a widely used anti-tuberculosis medication. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique components of mycobacterial cell wall.
Rifampicin
Rifampicin is a widely used anti-tuberculosis medication.
Pyrazinamide
Pyrazinamide is a commonly used medication for tuberculosis, with bactericidal effect against intracellular mycobacterium tuberculosis.
Ethambutol
Ethambutol is a widely used medicine in anti-TB regimens with bacteriostatic effect against M. tb.
Control regimen group
The control all oral regimen consisted of isoniazid,rifampin, pyrazinamide, and ethambutol during the intensive phase of treatment (2 months), followed by isoniazid and rifampin during the continuation phase (4 months).
Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg((less than 50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less than 50kg,once daily) or 1000mg (more than 50kg,once daily).
.
Isoniazid
Isoniazid is a widely used anti-tuberculosis medication. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique components of mycobacterial cell wall.
Rifampicin
Rifampicin is a widely used anti-tuberculosis medication.
Pyrazinamide
Pyrazinamide is a commonly used medication for tuberculosis, with bactericidal effect against intracellular mycobacterium tuberculosis.
Ethambutol
Ethambutol is a widely used medicine in anti-TB regimens with bacteriostatic effect against M. tb.
Interventions
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Isoniazid
Isoniazid is a widely used anti-tuberculosis medication. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique components of mycobacterial cell wall.
Rifampicin
Rifampicin is a widely used anti-tuberculosis medication.
Pyrazinamide
Pyrazinamide is a commonly used medication for tuberculosis, with bactericidal effect against intracellular mycobacterium tuberculosis.
Ethambutol
Ethambutol is a widely used medicine in anti-TB regimens with bacteriostatic effect against M. tb.
Levofloxacin
Levofloxacin is a commonly used antimicrobial for TB and other infections, which acts on the DNA-DNA-gyrase complex and topoisomerase IV. It is the S (-) enantiomer of the racemic active substance ofloxacin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Hubei Provincial Center for Disease Control and Prevention
OTHER
Centre for Tuberculosis Control of Guangdong Province
UNKNOWN
Hunan Institute For Tuberculosis Control
UNKNOWN
Anhui Chest Hospital
OTHER
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
OTHER_GOV
Wuhan Institute for Tuberculosis Control
OTHER
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Shenyang Chest Hospital
OTHER
Changchun Infectious Disease Hospital
UNKNOWN
First Affiliated Hospital of Xinjiang Medical University
OTHER
Public Health Clinical Center of Chengdu
UNKNOWN
Taiyuan Fourth People's Hospital
UNKNOWN
The Sixth People's Hospital of Nantong
UNKNOWN
The Tuberculosis Prevention and Treatment Hospital of Shanxi Province
UNKNOWN
Beijing Research Institute for Tuberculosis Control
UNKNOWN
Infectious Disease Prevention Hospital in Heilongjiang Province
UNKNOWN
The Third People's Hospital of Zhenjiang
UNKNOWN
Tianjin centers for Disease Control and Prevention
UNKNOWN
Harbin Chest Hospital
UNKNOWN
Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC
UNKNOWN
Heilongjiang Province center for tuberculosis Control and Prevention
UNKNOWN
Tianjin Haihe Hospital
OTHER
The Infectious Disease Hospital of Wangkai Zaozhuang
UNKNOWN
The Third People's Hospital of Kunming City
UNKNOWN
Kaifeng Central Hospital
OTHER
The Infectious Hospital of Hebi
UNKNOWN
Pulmonary Hospital of Lanzhou
UNKNOWN
The Fourth People's Hospital of Ningxia Autonomous Region
UNKNOWN
The Fourth People's Hospital of Qinghai Province
OTHER
The Fifth People's Hospital of Suzhou
OTHER
Chongqing Infectious Disease Medical Center
UNKNOWN
Tuberculosis Hospital in Jilin Province
UNKNOWN
Sixth People's Hospital of Nanyang City
UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Beijing Chest Hospital
OTHER
Responsible Party
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Tang Shenjie
Director, TB Department
Principal Investigators
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Shenjie Tang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Chest Hospital
Locations
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Anhui Chest Hospital
Hefei, Anhui, China
Beijing Research Institute for Tuberculosis Control
Beijing, Beijing Municipality, China
Beijing Chest Hospital,Capital Meical University
Beijing, Beijing Municipality, China
Chongqing Infectious Disease Medical Center
Chongqing, Chongqing Municipality, China
Pulmonary Hospital of Lanzhou
Lanzhou, Gansu, China
Centre for Tuberculosis Control of Guangdong Province
Guangzhou, Guangdong, China
Guangxi Center for Disease Prevention and Control
Nanning, Guangxi, China
HeBei Province Center for Disease Prevention and Control
Shijiazhuang, Hebei, China
Heilongjiang Province center for tuberculosis Control and Prevention
Haerbin, Heilongjiang, China
Harbin Chest Hospital
Harbin, Heilongjiang, China
Infectious Disease Prevention Hospital in Heilongjiang Province
Harbin, Heilongjiang, China
The Infectious Hospital of Hebi
Hebi, Henan, China
Kaifeng Pulmonary Disease Hospital
Kaifeng, Henan, China
Sixth People's Hospital of Nanyang City
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xianxiang, Henan, China
Wuhan medical treatment center
Wuhan, Hubei, China
Wuhan Institute For Tuberculosis Control
Wuhan, Hubei, China
Hunan Institute For Tuberculosis Control
Changsha, Hunan, China
The Sixth People's Hospital of Nantong
Nantong, Jiangsu, China
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
The Third People's Hospital of Zenjiang
Zhenjiang, Jiangsu, China
Changchun Infectious Disease Hospital
Changchun, Jilin, China
Tuberculosis Hospital in Jilin Province
Jilin, Jilin, China
China Shenyang Chest Hospital
Shenyang, Jilin, China
The Fourth People's Hospital of Ningxia Autonomous Region
Yinchuan, Ningxia, China
The 4th People's Hospital of Qinghai Province
Xining, Qinghai, China
The Infectious Disease Hospital of Wangkai Zaozhuang
Tengzhou, Shandong, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Taiyuan Fourth People's Hospital
Taiyuan, Shanxi, China
The Tuberculosis Prevention and Treatment Hospital of Shanxi Province
Xi’an, Shanxi, China
Public Health Clinical Center of Chengdu
Chengdu, Sichuan, China
Tianjin Haihe Hospital
Tianjin, Tianjin Municipality, China
Tianjin centers for Disease Control and Prevention
Tianjin, Tianjin Municipality, China
Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC
Ürümqi, Xinjiang, China
The Third People's Hospital of Kunming City
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2015ZX10003001
Identifier Type: -
Identifier Source: org_study_id
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