Evidence Hub

Levofloxacin Prophylaxis in Children Exposed to MDR Tuberculosis

AAP Grand Rounds, 2025

922 participants

Abstract

Source: Hesseling AC, Purchase SE, Martinson NA, et al. Levofloxacin preventive treatment in children exposed to MDR tuberculosis. N Engl J Med. 2024;391(24):2315-2326; doi: 10.1056/NEJMoa2314318.Investigators from multiple institutions conducted a randomized controlled trial to assess the efficacy and safety of levofloxacin in preventing tuberculosis (TB) in children who were household contacts of an adult with multiple drug resistant (MDR) TB. The study was conducted at 5 sites in South Africa between 2017 and 2023. Participants were children 80% of participants in each group. By study week 48, 5 (1.1%) children in the levofloxacin group had developed TB compared to 12 (2.6%) of those assigned to placebo (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.15, 1.25; P = 0.12). Incident TB had occurred by 72 weeks in 6 (1.3%) participants assigned to levofloxacin and 13 (2.8%) in the placebo group (HR, 0.49; 95% CI, 0.18, 1.30). A significant adverse event that possibly was related to study medication occurred during the treatment period in 0.9% and 1.7% of participants randomized to levofloxacin or placebo, respectively. One child receiving levofloxacin had grade 2 tendonitis, which resolved within 21 days after stopping treatment.The authors conclude that levofloxacin treatment was not significantly associated with a reduced risk of TB in children with an adult household contact with MDR TB.Dr Brady has disclosed no financial relationship relevant to this commentary.…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 922 participants or records.

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