Suryavanshi, N., Draper, H. R., Dhumal, G., Bagchi, S., Castillo-Carandang, N. T., Marthinus, A., Cheong, A. M. A., Kinikar, A., Paradkar, M., Gupta, A., Ocampo, J. D. R., Frias, M. V. G., 4th, Casalme, D. J. O., Hesseling, A., Garcia-Prats, A. J., Palmer, M., Hoddinott, G., Viljoen, L., & CATALYST Trial Team (2025). Acceptability of 100-mg moxifloxacin in children with rifampicin-resistant TB in three high-burden countries. IJTLD open, 2(10), 597–603. https://doi.org/10.5588/ijtldopen.25.0365

Summary

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 = 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.

Keywords: DR-TB; dispersible drug; drug-resistant; palatability; tuberculosis.


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