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

Abstract

<sec id="st1"><title>BACKGROUND</title>We evaluated the palatability and acceptability of a 100 mg dispersible and a non-dispersible 250 mg levofloxacin (LVX) tablet formulation in children.</sec><sec id="st2"><title>METHODS</title>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.</sec><sec id="st3"><title>RESULTS</title>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 (n = 14, 56%), vomiting/spitting out medicines (n = 11, 44%), and children refusing medicines (n = 10, 40%). Caregivers reported that the dispersible formulation was easier for their child to take than the non-dispersible formulation (P = 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 F 11.120; P < 0.0038); post-hoc testing showed dispersible tablets were preferred over non-dispersible (P = 0.018) and routinely available LVX formulations (P < 0.001).</sec><sec id="st4"><title>CONCLUSIONS</title>The dispersible LVX 100 mg tablet formulation was preferred and should be prioritised for integration into routine care.</sec>