Levofloxacin for the Prevention of Multidrug-Resistant Tuberculosis in Vietnam

This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 6-month levofloxacin regimen to prevent active tuberculosis among 2041 household contacts of patients with rifampicin-resistant or multidrug-resistant (MDR) tuberculosis in Vietnam. Participants with latent M. tuberculosis infection were randomized to receive daily weight-based levofloxacin or placebo. Over 30 months, bacteriologically confirmed tuberculosis occurred in 0.6% of the levofloxacin group and 1.1% of the placebo group (incidence rate ratio, 0.55; 95% CI, 0.19–1.62), a non-significant difference. Adverse events were more frequent with levofloxacin (31.9% vs. 13.0%), though serious events were rare and no acquired fluoroquinolone resistance was detected. The trial suggests levofloxacin may reduce TB incidence among contacts, but low event rates and high dropout due to mild side effects limit definitive conclusions. Findings complement the TB-CHAMP trial and support further evaluation of fluoroquinolone-based preventive therapy.

This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 6-month levofloxacin regimen to prevent active tuberculosis among 2041 household contacts of patients with rifampicin-resistant or multidrug-resistant (MDR) tuberculosis in Vietnam. Participants with latent M. tuberculosis infection were randomized to receive daily weight-based levofloxacin or placebo. Over 30 months, bacteriologically confirmed tuberculosis occurred in 0.6% of the levofloxacin group and 1.1% of the placebo group (incidence rate ratio, 0.55; 95% CI, 0.19–1.62), a non-significant difference. Adverse events were more frequent with levofloxacin (31.9% vs. 13.0%), though serious events were rare and no acquired fluoroquinolone resistance was detected. The trial suggests levofloxacin may reduce TB incidence among contacts, but low event rates and high dropout due to mild side effects limit definitive conclusions. Findings complement the TB-CHAMP trial and support further evaluation of fluoroquinolone-based preventive therapy.