NCT05047055Completed
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 550 (actual)
- First submitted
- 8 Sept 2021
- Start date
- 15 Mar 2022
- Primary completion date
- 17 Apr 2026
- Lead sponsor
- Tuberculosis Research Centre, India
- Diseases
- Tuberculosis
- NCT number
- NCT05047055
What you commit to
- Study type: Observational
- Participants enrolled: 550
- From 15 Mar 2022 to the primary completion date, 17 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- QTcF\> 450 ms or bundle branch block or heart block on ECG
- Psychiatric illness
- Seizure disorder
Lab values
- 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.
Other
- Body weight less than 30 kg
- 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
- Pregnancy or lactation
- Those seriously ill as defined by a score of \<50 on Karnofsky scale (Annexure 1)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute for Research in Tuberculosis Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.