Journal Article

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

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

2024

Overview

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: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adult / Antibiotics / Antitubercular Agents - administration & dosage / Antitubercular Agents - adverse effects / Antitubercular Agents - therapeutic use / Biopsy / Care and treatment / Clinical trials / Comparative analysis / Dosage and administration / Drug Administration Schedule / Drug dosages / Drug therapy / Drug Therapy, Combination / Effectiveness / Ethambutol / Ethambutol - administration & dosage / Ethambutol - adverse effects / Ethambutol - therapeutic use / Evaluation / Extra pulmonary tuberculosis / Female / HIV / Human immunodeficiency virus / Humans / India / Infectious Diseases / Internal Medicine / Isoniazid / Isoniazid - administration & dosage / Isoniazid - adverse effects / Isoniazid - therapeutic use / Lymph node tuberculosis / Lymph nodes / Lymphadenitis / Lymphatic diseases / Lymphatic system / Male / Medical Microbiology / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / Methods / Middle Aged / Ofloxacin / Ofloxacin - administration & dosage / Ofloxacin - adverse effects / Ofloxacin - therapeutic use / Parasitology / Patients / Physiological aspects / Product development / Pyrazinamide / Pyrazinamide - administration & dosage / Pyrazinamide - adverse effects / Pyrazinamide - therapeutic use / Rifampin / Rifampin - administration & dosage / Rifampin - adverse effects / Rifampin - therapeutic use / Side effects / Sinuses / Testing / Toxicity / Toxicity testing / Treatment Outcome / Tropical Medicine / Tuberculosis / Tuberculosis, Lymph Node - drug therapy / X-rays / Young Adult