Multi-centric Prospective Cohort Study of TB Recurrence Free Cure Among Microbiologically Confirmed New Pulmonary Tuberculosis Patients Treated Under NTEP With the 4-month Moxifloxacin Containing Daily Regimen
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- TB recurrence free cure
研究概览
简要总结
The 4-month daily regimen containing moxifloxacin (2HRZEM 7 / 2HRM7) of ICMR-NIRT was studied in 321 sputum positive pulmonary TB patients in a randomised clinical trial. Of the 321, there were 96% with sputum smear grading of 2+/3+ and 80% with >2 zone involvement in the chest radiograph, The sputum culture conversion at the end of intensive phase was 94%, favourable response at the end of treatment of 92% and the TB recurrence rate was 4.1%. The regimen was safe and well tolerated.
The advantages of a 33% reduction in treatment duration are manifold in terms of financial and other administrative implications. As the next logical step investigators believe that the effectiveness of this shortened regimen that proved successful in our study needs to be tested in the field. Under NTEP the anti-TB drugs are offered as Fixed dose Combination (FDC).3 The HREZ intensive phase and HRE continuation phase FDC are administered to patients based on body weight category. If our proposed study proves successful, the addition of moxifloxacin tablet to the FDC of anti-TB drugs in the intensive and continuation phases of treatment would be feasible under TB program settings. Investigators propose to evaluate 4-month moxifloxacin containing daily regimen [2 months of HRZEM daily / 2 months of HREM daily (2 HRZEM 7 / 2HREM7)] in the treatment of newly diagnosed sputum smear positive pulmonary TB patients.
详细描述
Scientific rationale The 4-month daily regimen containing moxifloxacin (2HRZEM 7 / 2HRM7) of ICMR-NIRT was studied in 321 sputum positive pulmonary TB patients in a randomised clinical trial.7 Of the 321, there were 96% with sputum smear grading of 2+/3+ and 80% with >2 zone involvement in the chest radiograph, The sputum culture conversion at the end of intensive phase was 94%, favourable response at the end of treatment of 92% and the TB recurrence rate was 4.1%. The regimen was safe and well tolerated.
The advantages of a 33% reduction in treatment duration are manifold in terms of financial and other administrative implications. As the next logical step investigators believe that the effectiveness of this shortened regimen that proved successful in our study needs to be tested in the field. Under NTEP the anti-TB drugs are offered as Fixed dose Combination (FDC). The HREZ intensive phase and HRE continuation phase FDC are administered to patients based on body weight category. If our proposed study proves successful, the addition of moxifloxacin tablet to the FDC of anti-TB drugs in the intensive and continuation phases of treatment would be feasible under TB program settings. Investigators propose to evaluate 4-month moxifloxacin containing daily regimen [2 months of HRZEM daily / 2 months of HREM daily (2 HRZEM 7 / 2HREM7)] in the treatment of newly diagnosed sputum smear positive pulmonary TB patients.
Objectives :
Primary objective:
To determine the TB recurrence free cure rate among microbiologically confirmed new pulmonary tuberculosis (PTB) patients treated under NTEP with the 4-month moxifloxacin containing daily regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years
- •At least one sputum smear and or CBNAAT test should be positive for tubercle bacilli
- •Female participants of childbearing potential must have a negative urine pregnancy test at screening. Those who have not undergone permanent sterilisation - tubal ligation or spouse with vasectomy must agree for use of contraceptive measures for birth control - vaginal diaphragm, intrauterine device, condom until treatment completion.
- •Willing to follow the trial procedures
- •Willing to give written informed consent
- •Residing within the study TU
排除标准
- •Body weight less than 30 kg
- •Previous anti-TB treatment, if any, should not exceed one month in the past 2 years and more than 7 days in the preceding one month
- •Multidrug resistant TB (MDR-TB)
- •Resistance to isoniazid or rifampicin or quinolone as evidenced by Cartridge based Nucleic acid Amplification test (CBNAAT) and Line probe Assay (LPA) test
- •Associated extra-pulmonary TB except TB superficial lymphadenitis
- •Hepatic or renal disease as evidenced by clinical or biochemical abnormalities- ALT/AST> 2.5 times ULN or Total bilirubin >1.2 mg/dl, Serum Creatinine >1.2 mg/dl, Blood Urea >43 mg/dl.
- •QTcF> 450 ms or bundle branch block or heart block on ECG
- •Psychiatric illness
- •Seizure disorder
- •Pregnancy or lactation
- •Those seriously ill as defined by a score of <50 on Karnofsky scale (Annexure 1)
研究组 & 干预措施
Single Group - 4 months moxifloxacin group
Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E), Moxifloxacin (M)
Isoniazid, rifampicin, pyrazinamide, ethambutol and moxifloxacin daily for 2 months followed by isoniazid, rifampicin, ethambutol and moxifloxacin daily for 2 months (2 HRZEM daily / 2HREM daily) - Duration 4 months
Drug dosages The Fixed-dose Combination (FDC) for HRZE(75/150/400/275mg) used under NTEP according to weight category will be used.
The patients enrolled in the study will receive an additional tablet of moxifloxacin(M) 400mg (body weight <64 Kg) / 600mg (body weight >65 Kg) along with the FDC both in the intensive and continuation phase.
干预措施: Isoniazid (Drug)
Single Group - 4 months moxifloxacin group
Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E), Moxifloxacin (M)
Isoniazid, rifampicin, pyrazinamide, ethambutol and moxifloxacin daily for 2 months followed by isoniazid, rifampicin, ethambutol and moxifloxacin daily for 2 months (2 HRZEM daily / 2HREM daily) - Duration 4 months
Drug dosages The Fixed-dose Combination (FDC) for HRZE(75/150/400/275mg) used under NTEP according to weight category will be used.
The patients enrolled in the study will receive an additional tablet of moxifloxacin(M) 400mg (body weight <64 Kg) / 600mg (body weight >65 Kg) along with the FDC both in the intensive and continuation phase.
干预措施: Rifampicin (Drug)
Single Group - 4 months moxifloxacin group
Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E), Moxifloxacin (M)
Isoniazid, rifampicin, pyrazinamide, ethambutol and moxifloxacin daily for 2 months followed by isoniazid, rifampicin, ethambutol and moxifloxacin daily for 2 months (2 HRZEM daily / 2HREM daily) - Duration 4 months
Drug dosages The Fixed-dose Combination (FDC) for HRZE(75/150/400/275mg) used under NTEP according to weight category will be used.
The patients enrolled in the study will receive an additional tablet of moxifloxacin(M) 400mg (body weight <64 Kg) / 600mg (body weight >65 Kg) along with the FDC both in the intensive and continuation phase.
干预措施: Pyrazinamide (Drug)
Single Group - 4 months moxifloxacin group
Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E), Moxifloxacin (M)
Isoniazid, rifampicin, pyrazinamide, ethambutol and moxifloxacin daily for 2 months followed by isoniazid, rifampicin, ethambutol and moxifloxacin daily for 2 months (2 HRZEM daily / 2HREM daily) - Duration 4 months
Drug dosages The Fixed-dose Combination (FDC) for HRZE(75/150/400/275mg) used under NTEP according to weight category will be used.
The patients enrolled in the study will receive an additional tablet of moxifloxacin(M) 400mg (body weight <64 Kg) / 600mg (body weight >65 Kg) along with the FDC both in the intensive and continuation phase.
干预措施: Ethambutol (Drug)
Single Group - 4 months moxifloxacin group
Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E), Moxifloxacin (M)
Isoniazid, rifampicin, pyrazinamide, ethambutol and moxifloxacin daily for 2 months followed by isoniazid, rifampicin, ethambutol and moxifloxacin daily for 2 months (2 HRZEM daily / 2HREM daily) - Duration 4 months
Drug dosages The Fixed-dose Combination (FDC) for HRZE(75/150/400/275mg) used under NTEP according to weight category will be used.
The patients enrolled in the study will receive an additional tablet of moxifloxacin(M) 400mg (body weight <64 Kg) / 600mg (body weight >65 Kg) along with the FDC both in the intensive and continuation phase.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
TB recurrence free cure
时间窗: 24 months after treatment
The proportion of microbiologically confirmed new PTB patients with TB recurrence free cure among those treated with the 4-month moxifloxacin containing daily regimen.
次要结局
- TB Sustained treatment Success, failure, death, loss to follow up(10 months)
- Adverse drug reaction(4 months, at the end of treatment)
- TB Relapse and Reinfection(24 months after treatment)
研究者
Banu Rekha
Scientist E
Tuberculosis Research Centre, India