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 Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 2,500
- Locations
- 1
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 14.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
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
- •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.
Investigators
Dr PK Bhavani
ICMR - National Institute for Research in Tuberculosis