Can we cure pulmonary tuberculosis faster with reappearance of TB disease? Comparing High-dose Rifampicin treatment plans with and without levofloxacin.

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 - PRaCTISe-HR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/102698

Enrollment

2500

Registered

2026-02-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: 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 wee

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients cured and disease (recurrence) free and alive at 2 years post treatment randomizationTimepoint: At End of Treatment (4 or 6 months)	—

Secondary

Measure	Time frame
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. Timepoint: At 18 months (Post randomisation) At 2 Years (Post treatment) Both time points are for relapse.	—

Measure

Time frame

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. Timepoint: At 18 months (Post randomisation) At 2 Years (Post treatment) Both time points are for relapse.

—

Countries

India

Contacts

Public ContactDr G Narendran

ICMR - National Institute for Research in Tuberculosis

gopalannaren@yahoo.co.in7338886190

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026