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.

Humans Ofloxacin / administration & dosage Adult Male Female Tuberculosis, Lymph Node / drug therapy Antitubercular Agents / therapeutic use Treatment Outcome Middle Aged India Rifampin / therapeutic use Young Adult Isoniazid / therapeutic use Drug Therapy, Combination Pyrazinamide / therapeutic use Ethambutol / therapeutic use Drug Administration Schedule Adolescent

Biopsy Extra pulmonary tuberculosis Lymphadenitis Ofloxacin Tuberculosis

Journal

BMC infectious diseases

ISSN: 1471-2334

Titre abrégé: BMC Infect Dis

Pays: England

ID NLM: 100968551

Informations de publication

Date de publication:
25 Jul 2024

Historique:

received: 23 11 2023

accepted: 13 06 2024

medline: 26 7 2024

pubmed: 26 7 2024

entrez: 25 7 2024

Statut: epublish

Résumé

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. 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. 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. The 4-month ofloxacin containing regimen was found to be non-inferior and as safe as the 6-month thrice-weekly control regimen.

Sections du résumé

BACKGROUND BACKGROUND

METHODS 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 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 CONCLUSIONS

The 4-month ofloxacin containing regimen was found to be non-inferior and as safe as the 6-month thrice-weekly control regimen.

Identifiants

DOI: 10.1186/s12879-024-09511-w PMID: 39054415

pubmed: 39054415

doi: 10.1186/s12879-024-09511-w

pii: 10.1186/s12879-024-09511-w

doi:

Substances chimiques

Ofloxacin A4P49JAZ9H

Antitubercular Agents 0

Rifampin VJT6J7R4TR

Isoniazid V83O1VOZ8L

Pyrazinamide 2KNI5N06TI

Ethambutol 8G167061QZ

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

729

Informations de copyright

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