Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide
NCT ID: NCT02120638
Last Updated: 2014-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2014-04-30
2016-04-30
Brief Summary
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Detailed Description
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The participants will be followed up to 24 months after the start of the treatment. The primary outcome is the sputum culture conversion and the adverse events. Safety evaluations that will be performed are the routine lab tests, blood glucose, hearing , vital signs, ECG, reporting of adverse events, physical examinations and X-rays.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pyrazinamide Sensitive Comparator
Pyrazinamide containing regimen: Regimen B1 - 6ZAmkLfxClrPto\\6ZlfxClrPto
* Six months of chemotherapy with Pyrazinamide,Amikacin,Levofloxacin,Clarithromycin,plus Prothionamide,followed by
* Six months of Pyrazinamide,Levofloxacin,Clarithromycin,plus Prothionamide
Pyrazinamide containing regimen
Pyrazinamide 33-50kg 1000-1750 mg daily, 51-70kg 1750-2000 daily, \>70kg 2000-2500mg daily Amikacin 600mg daily Levofloxacin 33-70kg 750 mg daily, \>70kg 1000 mg daily Clarithromycin 33-50kg 500 mg daily, \>50kg 1000 mg daily Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, \>70kg 1000 mg daily All treatment is taken daily, for a duration of up to 12 months depending on treatment arm.
Pyrazinamide Resistant Comparator
Regimen without Pyrazinamide: Regimen B2 - 6HAmkLfxClrPto\\18HlfxClrPto
* Six months of chemotherapy with Isoniazid,Amikacin,Levofloxacin,Clarithromycin,plus Prothionamide,followed by
* Eighteen months of Isoniazid,Levofloxacin,Clarithromycin,plus Prothionamide
Regimen without Pyrazinamide
Isoniazid 600mg daily Amikacin 600mg daily Levofloxacin 33-70kg 750 mg daily, \>70kg 1000 mg daily Clarithromycin 33-50kg 500 mg daily, \>50kg 1000 mg daily Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, \>70kg 1000 mg daily All treatment is taken daily, for a duration of up to 18 months depending on treatment arm.
Interventions
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Pyrazinamide containing regimen
Pyrazinamide 33-50kg 1000-1750 mg daily, 51-70kg 1750-2000 daily, \>70kg 2000-2500mg daily Amikacin 600mg daily Levofloxacin 33-70kg 750 mg daily, \>70kg 1000 mg daily Clarithromycin 33-50kg 500 mg daily, \>50kg 1000 mg daily Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, \>70kg 1000 mg daily All treatment is taken daily, for a duration of up to 12 months depending on treatment arm.
Regimen without Pyrazinamide
Isoniazid 600mg daily Amikacin 600mg daily Levofloxacin 33-70kg 750 mg daily, \>70kg 1000 mg daily Clarithromycin 33-50kg 500 mg daily, \>50kg 1000 mg daily Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, \>70kg 1000 mg daily All treatment is taken daily, for a duration of up to 18 months depending on treatment arm.
Eligibility Criteria
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Inclusion Criteria
* Patients who are smear positive and sputum culture positive for tuberculosis
* History of active tuberculosis less than 3 years
* With less than 2 times of previous antituberculous therapy
* The patients should be voluntarily entering the study and willing to sign up the consent form after full knowledge of the risks, schedule, drug features of this study.
* MDR-TB is defined as resistance to the following two drugs: Isoniazid and Rifampicin.
* Extensively drug-resistant(XDR-TB) is defined as resistance to any flouroquinolones and any one of the three second-line antituberculous injections (capreomycin, kanamycin, amikacin)
* The study enrolled MDR-TB subjects and excluded XDR-TB subjects. If MDR-TB subjects is also resistant to flouroquinolones or capreomycin( kanamycin, amikacin), the subjects is included in the study as pre-XDR TB patients.
Exclusion Criteria
* Liver damage (Hepatic encephalopathy; ascites; prothrombin time prolonged 2 seconds compared with normal controls; blood bilirubin 3 times greater than the upper limit of the normal range)
* Platelets \<150x109 / L, WBC \< 3x109 / L.
* Abnormal ECG (Male patients with prolonged QT interval exceeding 430ms, Female patients with prolonged QT interval exceeding 450ms)
* Serum creatinine 1.5 times higher than upper limit
* Fasting blood-glucose higher than 8.0 mmol/L
* Patients who are on medication that effect the results of the drugs in this study
* Karnofsky score\<50% (see appendix)
* Women who are pregnant or breastfeeding
* HIV positive
* Participating in other clinical trials in the past three months
* Patients with mental illness and severe neurosis
* Patients who have poor compliances
* Any special circumstances in which the research physicians believe that is not suitable for this study.
18 Years
60 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Wen-hong Zhang
Director of Division of Infectious Diseases
Principal Investigators
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Ying Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital of Fudan University, Shanghai, China;Johns Hopkins University, Baltimore, Maryland, USA
Wenhong Zhang, PhD,MD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital of Fudan University, Shanghai, China
Locations
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Chongqing Pulmonary Hospital
Chongqing, Chongqing Municipality, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, China
Xinjiang Chest Hospital
Ürümqi, Xinjiang, China
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
The Affiliated Hospital of Luzhou Medical College
Huzhou, Zhejiang, China
Wenling No.1 People's Hospital
Taizhou, Zhejiang, China
Ruian People's Hospital
Wenzhou, Zhejiang, China
Zhuji People's Hospital of Zhejiang Province
Zhuji, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2013ZX10003008-003
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KY2013-260
Identifier Type: -
Identifier Source: org_study_id
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