Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05047055 |
| Other study ID # |
2021010 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2022 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Tuberculosis Research Centre, India |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
