NCT05047055

Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 550 (actual)
• Sponsor: Tuberculosis Research Centre, India · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Secondary objectives: 1. To determine the Adverse drug reactions (ADR) with the 4-month moxifloxacin containing daily regimen 2. To determine to response to treatment with the 4-month moxifloxacin containing daily regimen 3. To store paired samples of culture isolates of patients with TB recurrence for future genotyping. Study sites: Nagpur, Lucknow, Delhi, Hyderabad, Vellore (5 sites) Study population: Newly diagnosed adult sputum smear and or CBNAAT positive PTB patients Sample size calculated was 550 patients. Screening assessments Clinical evaluation, Laboratory evaluations will be done initially. Positive sputum isolates at baseline and at the time of TB recurrence will be sent to ICMR-NIRT, Chennai for storage for future genotyping. Follow-up Follow-up during treatment: During the treatment phase the patients will be followed every month Follow-up post- treatment : During post-treatment, the patients will be followed up once in 3 months at 3, 6, 9 and 12 months and once every six months upto 24 months (ie. at 18 and 24 months). The 95% confidence interval of the TB recurrence free cure rate will be used to conclude on the performance of the 4 month moxifloxacin containing regimen under program settings. Study duration: Recruitment, training of staff: 2 month Duration of enrollment : 10 months Duration of treatment: 4 months Follow-up period : 24 months post-treatment Data analysis and report generation : 2 months Total study duration: 3.5 years

Conditions

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	Isoniazid	Intensive Phase for 2 months and Continuation phase for 2 months dose: 75 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.
DRUG	Rifampicin	Intensive Phase for 2 months and Continuation phase for 2 months dose: 150 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.
DRUG	Pyrazinamide	Intensive Phase for 2 months only dose: 400 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.
DRUG	Ethambutol	Intensive Phase for 2 months and Continuation phase for 2 months dose: 275 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.
DRUG	Moxifloxacin	Intensive Phase for 2 months and Continuation phase for 2 months dose: 400 mg for 30 to 64 yrs AND 600 mg for 65 and above years of age.

Timeline

• Start date: 2022-03-15
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2021-09-16
• Last updated: 2024-01-05

Locations

1 site across 1 country: India