Multidrug Resistant Tuberculosis Clinical Trial
Official title:
Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide
Multidrug resistant tuberculosis (MDR-TB) is difficult to treat and raises a great challenge to TB control program. That pyrazinamide can shorten the course of treatment and facilitate bacilli clearance has been proved recently. In 2011, WHO recommended to use pyrazinamide throughout the course of treatment for MDR-TB. However, pyrazinamide susceptibility testing has not been widely used in clinic. And the conventional testing is time-consuming and unreliable. In contrast, the detection of pncA and rpsA mutations with molecular methods can provide rapid results of pyrazinamide susceptibility. The purpose of this study is to evaluate the efficacy of the introduce the molecular testing of pyrazinamide susceptibility in optimizing the MDR-TB treatment regimen.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patients who are diagnosed with active tuberculosis - 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: - Known allergy or intolerance to the drugs in this study - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Chongqing Pulmonary Hospital | Chongqing | Chongqing |
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 | The Fifth People's Hospital of Suzhou | Suzhou | Jiangsu |
China | Wenling No.1 People's Hospital | Taizhou | Zhejiang |
China | Xinjiang Chest Hospital | Urumqi | Xinjiang |
China | Ruian People's Hospital | Wenzhou | Zhejiang |
China | The Fifth People's Hospital of Wuxi | Wuxi | Jiangsu |
China | The Sixth People's Hospital of Zhengzhou | Zhengzhou | Henan |
China | Zhuji People's Hospital of Zhejiang Province | Zhuji | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Median Time to Sputum Culture Conversion | 24 months | No | |
Secondary | The Percentage of treatment success | Treatment success is defined as: During the last 12 months of treatment,participants have at least 5 sputum cultures negative taken at least 30 days apart. During the last 12 months of treatment,participants have only one sputum culture positive, followed by at least 3 consecutive sputum cultures negative taken at least 30 days apart, without symptoms progression. Participants complete the treatment, but less than 5 culture results are available. |
24 months | No |
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