BMC Infectious Diseases (Jul 2024)

Efficacy and tolerability of a 4-month ofloxacin-containing regimen compared to a 6-month regimen in the treatment of patients with superficial lymph node tuberculosis: a randomized trial

  • Syed Hissar,
  • Banurekha Velayutham,
  • Manoharan Tamizhselvan,
  • Sridhar Rathinam,
  • Chinnadurai Arunbabu,
  • Jayanthi Bharathi Vidhya,
  • Gurusamy Vargunapandian,
  • Anandakrishnan Sundararajaperumal,
  • Gomathi Narayan Sivaramakrishnan,
  • Silambu Chelvi,
  • Paranchi Murugesan Ramesh,
  • Damodharan Arun,
  • Sirasanambati Devarajulu Reddy,
  • Paramasivam Paul Kumaran,
  • Marimuthu Makesh Kumar,
  • Dharuman Kalaiselvi,
  • Luke Elizabeth Hanna,
  • Hemanth Kumar,
  • Alagarsamy Gowrisankar,
  • Ramasamy Rajavelu,
  • Lavanya Jayabal,
  • Chinnayan Ponnuraja,
  • Dhanaraj Baskaran

DOI
https://doi.org/10.1186/s12879-024-09511-w
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 9

Abstract

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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.

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