Acceptability of a 250 mg levofloxacin formulation in children receiving TB preventive treatment.

Background: Recent evidence indicates that levofloxacin (LFX) is effective in preventing TB in individuals exposed to multidrug-resistant TB (MDR-TB). Despite the need for pediatric formulations, the 250 mg adult LFX formulation is affordable and widely used for TB treatment and prevention in children.

Methods: TB-CHAMP (Tuberculosis Child Multidrug-resistant Preventive Therapy ISRCTN92634082) was a trial of MDR-TB preventive treatment, comparing levofloxacin to placebo in children with MDR-TB exposure. Acceptability questionnaires were administered to caregivers at six timepoints during the 24-week treatment phase. Likert scales were used to grade 6 domains of acceptability, and a composite acceptability (CA) outcome was generated. Factors associated with acceptability were assessed using modified Poisson regression models to estimate risk ratios (RRs).

Results: Overall, 922 children were randomised, 453 to LFX and 469 to placebo. By Week 8, 25.1% of children on LFX had poor CA versus 6.2% receiving placebo (Weeks 0-24: RR 3.43, 95% CI 2.69-4.37). Acceptability in the LFX arm improved from 36.8% poor CA at baseline to 12.9% at Week 24. Only 11.7% of children swallowing tablets whole/halved had poor CA outcomes at Week 8, compared to 34.4% swallowing crushed/softened tablets.

Conclusions: LFX 250 mg tablets have reasonable acceptability and could be used as an alternative to dispersible formulations, especially in children able to swallow tablets.