Tuberculosis, PulmonaryNCT05047055
Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients
An observational study of Tuberculosis, Pulmonary, run by Tuberculosis Research Centre, India at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Isoniazid, Rifampicin and Pyrazinamide
- Type of treatment
- Pill or oral medicine
- How many people
- 550 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2022to 17 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed adult sputum smear and or CBNAAT positive pulmonary TB patients
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
India1 site
National Institute for Research in Tuberculosis
Chennai, Tamil Nadu, 600031
About this study
Official title: 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
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.
Read the 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:
- To determine the Adverse drug reactions (ADR) with the 4-month moxifloxacin containing daily regimen
- To determine to response to treatment with the 4-month moxifloxacin containing daily regimen
- 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
- Being tested
- Isoniazid, Rifampicin, Pyrazinamide, Ethambutol, Moxifloxacin
- Keywords
- Pulmonary Tuberculosis
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
Also called H
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.
RifampicinDrug
Also called R
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.
PyrazinamideDrug
Also called Z
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.
EthambutolDrug
Also called E
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.
MoxifloxacinDrug
Also called M
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Isoniazid; Drug: Rifampicin; Drug: Pyrazinamide; Drug: Ethambutol; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB recurrence free cure
The proportion of microbiologically confirmed new PTB patients with TB recurrence free cure among those treated with the 4-month moxifloxacin containing daily regimen.
Measured: 24 months after treatment
Secondary outcomes (3)
Adverse drug reaction
The proportion of PTB patients with adverse drug reactions in those treated with the 4-month moxifloxacin containing daily regimen.
Measured: 4 months, at the end of treatment
TB Sustained treatment Success, failure, death, loss to follow up
The proportion of PTB patients with sustained treatment success, failure, death, lost to follow-up
Measured: 10 months
TB Relapse and Reinfection
The proportion of patients with TB relapse and TB re-infection based on genotyping
Measured: 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start15 Mar 2022
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuberculosis Research Centre, India
- Sponsor type
- Other government
- Collaborators
- Indira Gandhi Government Medical College and Hospital (IGGMCH), Nagpur, King George's Medical University, Lucknow, Mahavir Hospital and Research Centre, Hyderabad, Government Vellore Medical College and Hospital, Adukkamparai, Lok Nayak hospital, New Delhi
- Responsible party
- Principal investigator, Banu Rekha, Tuberculosis Research Centre, India
- Investigators
- Dr. Banurekha MBBS., MPH, Principal investigator, National Institute for Research in Tuberculosis, Chennai, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047055
- Sponsor's protocol ID
- 2021010
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2021
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05047055
- Acronym / sponsor ID
- 2021010
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- Pulmonary Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Tuberculosis Research Centre, IndiaOther government
- Collaborators
- Indira Gandhi Government Medical College and Hospital (IGGMCH), Nagpur, King George's Medical University, Lucknow, Mahavir Hospital and Research Centre, Hyderabad, Government Vellore Medical College and Hospital, Adukkamparai, Lok Nayak hospital, New Delhi
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the Adverse drug reactions (ADR) with the 4-month moxifloxacin containing daily regimen
- To determine to response to treatment with the 4-month moxifloxacin containing daily regimen
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group - 4 months moxifloxacin group | – | Drug: Isoniazid, Drug: Rifampicin, Drug: Pyrazinamide, Drug: Ethambutol, Drug: MoxifloxacinIsoniazid (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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed adult sputum smear and or CBNAAT positive pulmonary TB patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsoniazidAlso: HIntensive 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 | Single Group - 4 months moxifloxacin group |
| RifampicinAlso: RIntensive 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 | Single Group - 4 months moxifloxacin group |
| PyrazinamideAlso: ZIntensive 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 | Single Group - 4 months moxifloxacin group |
| EthambutolAlso: EIntensive 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 | Single Group - 4 months moxifloxacin group |
| MoxifloxacinAlso: MIntensive 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. | Drug | Single Group - 4 months moxifloxacin group |
Primary outcome
TB recurrence free cure
Time frame: 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.
3 secondary outcomes
Adverse drug reaction
Time frame: 4 months, at the end of treatment
TB Sustained treatment Success, failure, death, loss to follow up
Time frame: 10 months
TB Relapse and Reinfection
Time frame: 24 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis, Pulmonary
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
RecruitingPhase 2
BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
Tuberculosis
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
Recruiting
Channa Striata and Curcuma Domestica Supplementation in Patients With Active Pulmonary Tuberculosis
Pulmonary Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Banurekha MBBS., MPH principal investigator
National Institute for Research in Tuberculosis, Chennai, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by Tuberculosis Research Centre, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB recurrence free cure (time frame: 24 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.