Acceptability of 100-mg moxifloxacin in children with rifampicin-resistant TB in three high-burden countries

Abstract

BACKGROUND: Routinely, a 400-mg tablet of moxifloxacin is used in children with rifampicin-resistant TB (RR-TB), but it has very poor acceptability. We describe the acceptability of a 100-mg dispersible moxifloxacin among children and their caregivers in South Africa, India, and the Philippines. METHODS: This study is nested in a pharmacokinetics, safety, and acceptability trial of new formulations of clofazimine and moxifloxacin in children with RR-TB. Quantitative and qualitative data were collected at four time points over 24 weeks and were analysed descriptively and thematically. FINDINGS: Median age of participants (n ¼ 36) was 4.9 years. Children and caregivers from all three countries preferred the dispersible 100-mg moxifloxacin to the routine 400-mg tablet due to the relative ease of administration. The 100-mg formulation was unpalatably bitter. Children who were able to swallow the 100-mg formulation preferred to do so. The smaller size of the 100-mg tablets enhanced their ease of preparation and acceptability, although some older participants experienced the increase in the number of tablets (compared with single 400-mg tablet) as a burden. CONCLUSION: The 100-mg moxifloxacin dispersible formulation is preferred over 400-mg. Overall, moxifloxacin palatability remains sub-optimal, and there is a need to further improve the acceptability of RR-TB treatments for children.