Acceptability of a 250 mg levofloxacin formulation in children receiving TB preventive treatment
Abstract
SUMMARY 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. CONCLUSION LFX 250 mg tablets have reasonable acceptability and could be used as an alternative to dispersible formulations, especially in children able to swallow tablets.
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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