Levofloxacin Preventive Treatment in Children Exposed to MDR Tuberculosis

This double-blind, cluster-randomized, placebo-controlled trial (TB-CHAMP) evaluated the efficacy and safety of levofloxacin as preventive treatment in 922 children exposed to household contacts with bacteriologically confirmed multidrug-resistant (MDR) pulmonary tuberculosis in South Africa. Children under 5 were enrolled regardless of HIV or IGRA status; older children were eligible if HIV-positive or IGRA-positive. Participants received daily levofloxacin or placebo for 24 weeks. By week 48, incident tuberculosis occurred in 1.1% of the levofloxacin group and 2.6% of the placebo group (HR, 0.44; 95% CI, 0.15–1.25), a non-significant difference. Safety was acceptable, with no serious drug-related concerns; grade ≥3 adverse events occurred in 0.9% (levofloxacin) vs. 1.7% (placebo). One case of grade 2 tendonitis was reported. The trial suggests levofloxacin may reduce TB incidence in exposed children, but low event rates and wide confidence intervals limit definitive conclusions. Findings complement the VQUIN MDR trial and inform global policy on pediatric MDR-TB prophylaxis.

This double-blind, cluster-randomized, placebo-controlled trial (TB-CHAMP) evaluated the efficacy and safety of levofloxacin as preventive treatment in 922 children exposed to household contacts with bacteriologically confirmed multidrug-resistant (MDR) pulmonary tuberculosis in South Africa. Children under 5 were enrolled regardless of HIV or IGRA status; older children were eligible if HIV-positive or IGRA-positive. Participants received daily levofloxacin or placebo for 24 weeks. By week 48, incident tuberculosis occurred in 1.1% of the levofloxacin group and 2.6% of the placebo group (HR, 0.44; 95% CI, 0.15–1.25), a non-significant difference. Safety was acceptable, with no serious drug-related concerns; grade ≥3 adverse events occurred in 0.9% (levofloxacin) vs. 1.7% (placebo). One case of grade 2 tendonitis was reported. The trial suggests levofloxacin may reduce TB incidence in exposed children, but low event rates and wide confidence intervals limit definitive conclusions. Findings complement the VQUIN MDR trial and inform global policy on pediatric MDR-TB prophylaxis.