Author:
Hissar Syed,Velayutham Banurekha,Tamizhselvan Manoharan,Rathinam Sridhar,Arunbabu Chinnadurai,Vidhya Jayanthi Bharathi,Vargunapandian Gurusamy,Sundararajaperumal Anandakrishnan,Sivaramakrishnan Gomathi Narayan,Chelvi Silambu,Ramesh Paranchi Murugesan,Arun Damodharan,Reddy Sirasanambati Devarajulu,Kumaran Paramasivam Paul,Kumar Marimuthu Makesh,Kalaiselvi Dharuman,Hanna Luke Elizabeth,Kumar Hemanth,Gowrisankar Alagarsamy,Rajavelu Ramasamy,Jayabal Lavanya,Ponnuraja Chinnayan,Baskaran Dhanaraj
Abstract
Abstract
Background
Tuberculosis (TB) lymphadenitis is the most common form of extra-pulmonary TB, and the treatment duration is six months. This non-inferiority based randomized clinical trial in South India evaluated the efficacy and safety of a four-month ofloxacin containing regimen in tuberculosis lymphadenitis (TBL) patients.
Methods
New, adult, HIV-negative, microbiologically and or histopathologically confirmed superficial lymph node TB patients were randomized to either four-month oflaxacin containing test regimen [ofloxacin (O), isoniazid (H), rifampicin (R), pyrazinamide (Z) -2RHZO daily/ 2RHO thrice-weekly] or a six-month thrice-weekly control regimen (2HRZ, ethambutol/4RH). The treatment was directly observed. Clinical progress was monitored monthly during and up to 12 months post-treatment, and thereafter every three months up to 24 months. The primary outcome was determined by response at the end of treatment and TB recurrence during the 24 months post-treatment.
Results
Of the 302 patients randomized, 298 (98.7%) were eligible for modified intention-to-treat (ITT) analysis and 294 (97%) for per-protocol (PP) analysis. The TB recurrence-free favourable response in the PP analysis was 94.0% (95% CI: 90.1–97.8) and 94.5% (95% CI: 90.8–98.2) in the test and control regimen respectively, while in the ITT analysis, it was 92.7% and 93.2%. The TB recurrence-free favourable response in the test regimen was non-inferior to the control regimen 0.5% (95% CI: -4.8-5.9) in the PP analysis based on the 6% non-inferiority margin. Treatment was modified for drug toxicity in two patients in the test regimen, while one patient had a paradoxical reaction.
Conclusion
The 4-month ofloxacin containing regimen was found to be non-inferior and as safe as the 6-month thrice-weekly control regimen.
Publisher
Springer Science and Business Media LLC
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