Acceptability of levofloxacin dispersible and non-dispersible tablet formulations in children receiving TB preventive treatment.

Background: We evaluated the palatability and acceptability of a 100 mg dispersible and a non-dispersible 250 mg levofloxacin (LVX) tablet formulation in children.

Methods: Perform was a randomised, open-label, cross-over trial of the relative bioavailability of LVX dispersible vs. crushed non-dispersible tablets in children aged <6 years routinely receiving TB preventive treatment. Children and caregivers completed Likert- and ranking-type measures on the acceptability of both formulations. We used summary, comparative and ranking statistics to characterise formulation acceptability.

Results: A total of 25 children were enrolled (median age: 2.6 years, IQR 1.6-4.0). Caregivers reported frequent challenges with preventive therapy in routine care prior to study entry, including taste of tablets ( = 14, 56%), vomiting/spitting out medicines ( = 11, 44%), and children refusing medicines ( = 10, 40%). Caregivers reported that the dispersible formulation was easier for their child to take than the non-dispersible formulation ( = 0.0253). Mean ranks for caregiver's formulation preferences (dispersible tablets: 1.48, SD ±0.71; non-dispersible tablets: 2.12, SD ±0.67; routinely available formulations: 2.40 SD ±0.82) differed significantly (Friedman's 11.120; < 0.0038); post-hoc testing showed dispersible tablets were preferred over non-dispersible ( = 0.018) and routinely available LVX formulations ( < 0.001).

Conclusions: The dispersible LVX 100 mg tablet formulation was preferred and should be prioritised for integration into routine care.