Holistic acceptability of an adult levofloxacin formulation in children and adolescents on a tuberculosis preventive treatment trial

Susan E Purchase; Dillon T Wademan; Nosibusiso L Tshetu; Mohhadiah Rafique; Graeme Hoddinott; James A Seddon; H Simon Schaaf; Anneke C Hesseling

doi:10.1371/journal.pgph.0003381

Holistic acceptability of an adult levofloxacin formulation in children and adolescents on a tuberculosis preventive treatment trial

PLOS Glob Public Health. 2024 Jul 5;4(7):e0003381. doi: 10.1371/journal.pgph.0003381. eCollection 2024.

Authors

Susan E Purchase¹, Dillon T Wademan¹, Nosibusiso L Tshetu¹, Mohhadiah Rafique¹, Graeme Hoddinott¹, James A Seddon^{1

2}, H Simon Schaaf¹, Anneke C Hesseling¹

Affiliations

¹ Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
² Department of Infectious Disease, Imperial College London, London, United Kingdom.

Abstract

Drug-resistant tuberculosis (TB) is threatening global TB control. Although formulations designed for children are a priority, adult levofloxacin formulations are widely used in TB treatment and prevention. TB-CHAMP was a cluster-randomised, placebo-controlled trial evaluating the efficacy and safety of 24 weeks of daily levofloxacin to prevent TB in child and adolescent household contacts of adults with infectious multidrug-resistant TB. Nested in-depth longitudinal qualitative work was conducted in a subset of children and their caregivers to understand broader experiences of treatment acceptability. We conducted 41 interviews with 8 caregivers of children <6 years, and with 6 older children responding for themselves. Children who could not swallow the adult formulation whole, found the tablet unpalatable, although they learnt to tolerate the taste over time. Most caregivers and children came from families with substantial experience of TB, but felt they knew little about TB preventive therapy. Many families experienced challenging socio-economic circumstances. Poor acceptability was mitigated by sympathetic study personnel, assistance with transport and financial compensation. The adult formulation of levofloxacin was disliked by many younger children but was acceptable to children able to swallow the tablet whole. In addition to using acceptable drug formulations, TB preventive treatment implementation models should include patient education and should accommodate patients' socioeconomic challenges.

Copyright: © 2024 Purchase et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Grants and funding

TB-CHAMP was made possible thanks to Unitaid's funding of the BENEFIT Kids project to Stellenbosch University. Unitaid accelerates access to innovative health products and lays the foundations for their scale-up by countries and partners. Data collection for this study was funded by the South African National Research Foundation through a South African Research Chairs Initiative (SA NRF – Hesseling, SARChI). GH received the financial assistance of the European Union (Grant no. DCI-PANAF/2020/420-028), through the African Research Initiative for Scientific Excellence (ARISE), pilot programme. ARISE is implemented by the African Academy of Sciences with support from the European Commission and the African Union Commission. The contents of this document are the sole responsibility of the author(s) and can under no circumstances be regarded as reflecting the position of the European Union, the African Academy of Sciences, and the African Union Commission. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.