| CTRI Number |
CTRI/2026/02/102698 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can we cure pulmonary tuberculosis faster with reappearance of TB disease? Comparing High-dose Rifampicin treatment plans with and without levofloxacin. |
|
Scientific Title of Study
|
A Multi-Centric Parallel Arm Randomized Controlled Clinical trial to improve treatment outcomes among persons with drug sensitive pulmonary TB treated with 4 or 6 months of High dose Rifampicin containing regimens with or without Levofloxacin |
| Trial Acronym |
PRaCTISe-HR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PK Bhavani |
| Designation |
Scientist - E (Medical) |
| Affiliation |
ICMR - National Institute for Research in Tuberculosis |
| Address |
Department of Clinical Research, ICMR - National Institute for Research in Tuberculosis, No.1, Mayor Sathyamoorthy road, Chetpet, Chennai
Chennai
TAMIL NADU
600031
India |
| Phone |
9962934169 |
| Fax |
|
| Email |
bhavani.pk@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Narendran |
| Designation |
Scientist F |
| Affiliation |
ICMR - National Institute for Research in Tuberculosis |
| Address |
Department of Clinical Research, ICMR - National Institute for Research in Tuberculosis, No.1, Mayor Sathyamoorthy road, Chetpet, Chennai
Chennai
TAMIL NADU
600031
India |
| Phone |
7338886190 |
| Fax |
|
| Email |
gopalannaren@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Narendran |
| Designation |
Scientist F |
| Affiliation |
ICMR - National Institute for Research in Tuberculosis |
| Address |
Department of Clinical Research, ICMR - National Institute for Research in Tuberculosis, No.1, Mayor Sathyamoorthy road, Chetpet, Chennai
Chennai
TAMIL NADU
600031
India |
| Phone |
7338886190 |
| Fax |
|
| Email |
gopalannaren@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ICMR |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavani P K |
ICMR-National Institute for Research in Tuberculosis |
Room no.207, Department of Clinical research, No 1,Mayor Sathyamoorthy Road
Chetpet
Chennai
TAMIL NADU |
9962934169
bhavani.pk@icmr.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIRT- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 H R10 ZE /4H R10 E |
Intensive Phase: Two months of daily Rifampicin, Isoniazid, Pyrazinamide and Ethambutol
Continuation Phase: Four months of Rifampicin, Isoniazid, and Ethambutol |
| Intervention |
2 H R25 ZE L/2 H R25 E L |
Intensive Phase: Two months of daily treatment with High dose Rifampicin (25mg/kg), isoniazid, pyrazinamide, Ethambutol and Levofloxacin (750/1000mg)
Continuation Phase: Two months of daily high dose Rifampicin (25mg/kg), Isoniazid, Ethambutol and Levofloxacin.
|
| Intervention |
2 H R25 ZE/ 4 H R25 HE |
Intensive Phase: Two months of daily treatment with High dose Rifampicin (25mg/kg), isoniazid, pyrazinamide, and Ethambutol
Continuation Phase: Four months of daily treatment with high dose Rifampicin (25mg/kg), Isoniazid, and Ethambutol
|
| Intervention |
2H R25 ZE /4 H R10 E |
Intensive Phase: Two months of daily treatment with High dose Rifampicin (25mg/kg), isoniazid, pyrazinamide, and Ethambutol
Continuation Phase: Four months of weeks of daily conventional dose of Rifampicin, Isoniazid, and Ethambutol
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged above 14 years.
Symptomatic persons with newly diagnosed sputum positive PTB - NAAT and or smear should be positive for Mtb
Re treatment patients who had previous one episode of microbiologically confirmed (by smear and NAAT) pulmonary TB and currently symptomatic and sensitive to all first line anti-TB drugs
If HIV positive, CD4 greater than 150 cells per mm3 and willing to take ART if not already on it
Willing to follow the trial procedures.
|
|
| ExclusionCriteria |
| Details |
Anti-TB treatment, greater than 14 days in current illness
Resistance to rifampicin as evidenced by Nucleic acid Amplification test (NAAT) OR LPA
Patients with Extra-pulmonary TB who require extended duration of treatment.
HIV Patients on second line ART regimens.
Baseline Hepatic or renal disease as evidenced by clinical or biochemical abnormalities
- ALT/AST greater than 2.5 times ULN or Total bilirubin graeter than 1.2 mg per dl.
- Serum Creatinine greater than 1.2 mg per dl.
Pregnant or lactating mothers
Patients who are seriously ill including symptoms like pneumothorax or hemoptysis.
Patients with h/o of concomitant medications which may interfere with study drugs.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients cured and disease (recurrence) free and alive at 2 years post treatment randomization |
At End of Treatment (4 or 6 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients with grade 3 or 4 adverse drug reactions.
The proportion of PTB patients who require permanent change of high dose regimen to standard regimen due to adverse events
The proportion of PTB patients
-with smear & culture conversion at end of 2 months & at end of treatment
-with radiological clearance at 2 & 6 months
The proportion of patients with drug interactions between the high dose Rifampicin & other first line anti-TB drugs & concomitant medications
The cost effectiveness of different treatment regimens.
|
At 18 months (Post randomisation)
At 2 Years (Post treatment)
Both time points are for relapse. |
|
|
Target Sample Size
|
Total Sample Size="2500"
Sample Size from India="2500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Despite wide
implementation of highly efficacious regimen, Tuberculosis (TB) treatment
success rate is 88 percentage throughout the world. In India among patients who
were initiated on treatment the success rate ranges from 85 to 88 percent over
decades. Studies have shown that about 5 to10 percentage will have recurrent
TB. Patients with recurrent TB are more at risk of having drug resistant TB. Data
on TB recurrence rate among patients initiated on daily regimen is currently
limited. Evidences highlight the need for effective strategies to improve
treatment outcomes and reduce TB recurrence in India and Use of high-dosage rifampicin
in reducing relapse rates remains to be explored in large clinical trials. Researchers
have always been interested in two specific aspects of treatment, one is
shortening of TB treatment thereby aborting drug resistance and recurrences using
additional drugs and the other optimizing the drug dosages of existing drugs.
The current trial is being proposed to evaluate the two strategies tried in
order to reduce recurrences 1. Usage of High dose Rifampicin given either for 2
months or for 6 months along with other first line anti-TB drugs. 2. Addition
of a Fluoroquinolone along with high dose rifampicin to reduce the treatment
duration from 6 months to 4 months
|