Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries
BACKGROUND: Rifampicin-resistant TB (RR-TB) in children is frequently treated with clofazimine (CFZ), widely available as a 100mg gel capsule. This formulation is challenging to administer and is poorly acceptable to children and caregivers. Poor acceptability may negatively impact adherence and tre...
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International Union Against Tuberculosis and Lung Disease (The Union)
2025-08-01
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| Series: | IJTLD Open |
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| Online Access: | https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2025/00000002/00000008/art00006 |
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| author | L. Viljoen H.R. Draper N.T. Castillo-Carandang N. Suryavanshi A. Marthinus A.M.A. Cheong J.D.D. Ocampo G. Dhumal S. Bagchi D.T. Wademan A. Kinikar M. Paradkar M.V.G. Frias IV D.J.O. Casalme A.C. Hesseling A.J. Garcia-Prats M. Palmer G. Hoddinott on behalf of the CATALYST trial team |
| author_facet | L. Viljoen H.R. Draper N.T. Castillo-Carandang N. Suryavanshi A. Marthinus A.M.A. Cheong J.D.D. Ocampo G. Dhumal S. Bagchi D.T. Wademan A. Kinikar M. Paradkar M.V.G. Frias IV D.J.O. Casalme A.C. Hesseling A.J. Garcia-Prats M. Palmer G. Hoddinott on behalf of the CATALYST trial team |
| author_sort | L. Viljoen |
| collection | DOAJ |
| description | BACKGROUND: Rifampicin-resistant TB (RR-TB) in children is frequently treated with clofazimine (CFZ), widely available as a 100mg gel capsule. This formulation is challenging to administer and is poorly acceptable to children and caregivers. Poor acceptability may negatively impact adherence and treatment outcomes. We describe the acceptability of a novel 50mg CFZ tablet formulation among children in South Africa, India, and the Philippines. METHODS: Mixed methods assessments were completed in a moxifloxacin and CFZ safety and pharmacokinetics trial in children with RR-TB. Quantitative data were collected from 36 participants at 4 timepoints. A sub-sample of 26 child/caregiver dyads participated in ∼4 qualitative interviews. Descriptive statistics and thematic analysis were employed. FINDINGS: The median age of n=36 participants (South Africa n=20; India n=6; the Philippines n=10) was 4.9 years. The majority (29/36) received a CFZ gel capsule prior to switching to the tablet formulation. The 50mg tablet had better acceptability scores for taste (p=0.035), smell (p=0.035), and ease of swallowing (p=0.02) compared to gel capsules. Participants described the tablet formulation as easier to administer/take without a lingering smell or taste. Limited concerns were noted on staining. CONCLUSION: The novel 50mg CFZ tablet has better acceptability and should be prioritised for children wherever possible. |
| format | Article |
| id | doaj-art-0a3a50bbf472466688d8ca4bec97aefa |
| institution | DOAJ |
| issn | 3005-7590 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | International Union Against Tuberculosis and Lung Disease (The Union) |
| record_format | Article |
| series | IJTLD Open |
| spelling | doaj-art-0a3a50bbf472466688d8ca4bec97aefa2025-08-20T03:07:10ZengInternational Union Against Tuberculosis and Lung Disease (The Union)IJTLD Open3005-75902025-08-012847848510.5588/ijtldopen.25.03096Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countriesL. Viljoen0H.R. Draper1N.T. Castillo-Carandang2N. Suryavanshi3A. Marthinus4A.M.A. Cheong5J.D.D. Ocampo6G. Dhumal7S. Bagchi8D.T. Wademan9A. Kinikar10M. Paradkar11M.V.G. Frias IV12D.J.O. Casalme13A.C. Hesseling14A.J. Garcia-Prats15M. Palmer16G. Hoddinott17on behalf of the CATALYST trial teamDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;Department of Clinical Epidemiology, College of Medicine, University of the Philippines Manila, Philippines;Program on Social Innovation in Health, National Institutes of Health, University of the Philippines Manila, Philippines;Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;De La Salle Health Sciences Institute, Dasmariñas City, Cavite, the Philippines;Program on Social Innovation in Health, National Institutes of Health, University of the Philippines Manila, Philippines;Byramjee Jeejeebhoy Government Medical College -Johns Hopkins Clinical Research Site, Pune, India;Byramjee Jeejeebhoy Government Medical College -Johns Hopkins Clinical Research Site, Pune, India;Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;Department of Paediatrics, Byramjee Jeejeebhoy Government Medical College, Pune, India;Byramjee Jeejeebhoy Government Medical College -Johns Hopkins Clinical Research Site, Pune, India;De La Salle Health Sciences Institute, Dasmariñas City, Cavite, the Philippines;De La Salle Health Sciences Institute, Dasmariñas City, Cavite, the Philippines;Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa;BACKGROUND: Rifampicin-resistant TB (RR-TB) in children is frequently treated with clofazimine (CFZ), widely available as a 100mg gel capsule. This formulation is challenging to administer and is poorly acceptable to children and caregivers. Poor acceptability may negatively impact adherence and treatment outcomes. We describe the acceptability of a novel 50mg CFZ tablet formulation among children in South Africa, India, and the Philippines. METHODS: Mixed methods assessments were completed in a moxifloxacin and CFZ safety and pharmacokinetics trial in children with RR-TB. Quantitative data were collected from 36 participants at 4 timepoints. A sub-sample of 26 child/caregiver dyads participated in ∼4 qualitative interviews. Descriptive statistics and thematic analysis were employed. FINDINGS: The median age of n=36 participants (South Africa n=20; India n=6; the Philippines n=10) was 4.9 years. The majority (29/36) received a CFZ gel capsule prior to switching to the tablet formulation. The 50mg tablet had better acceptability scores for taste (p=0.035), smell (p=0.035), and ease of swallowing (p=0.02) compared to gel capsules. Participants described the tablet formulation as easier to administer/take without a lingering smell or taste. Limited concerns were noted on staining. CONCLUSION: The novel 50mg CFZ tablet has better acceptability and should be prioritised for children wherever possible.https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2025/00000002/00000008/art00006tuberculosisdrug-resistant tbdispersible tabletssouth africaindiaphilippines |
| spellingShingle | L. Viljoen H.R. Draper N.T. Castillo-Carandang N. Suryavanshi A. Marthinus A.M.A. Cheong J.D.D. Ocampo G. Dhumal S. Bagchi D.T. Wademan A. Kinikar M. Paradkar M.V.G. Frias IV D.J.O. Casalme A.C. Hesseling A.J. Garcia-Prats M. Palmer G. Hoddinott on behalf of the CATALYST trial team Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries IJTLD Open tuberculosis drug-resistant tb dispersible tablets south africa india philippines |
| title | Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries |
| title_full | Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries |
| title_fullStr | Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries |
| title_full_unstemmed | Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries |
| title_short | Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries |
| title_sort | acceptability of a clofazimine tablet in children with rifampicin resistant tb in three high burden countries |
| topic | tuberculosis drug-resistant tb dispersible tablets south africa india philippines |
| url | https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2025/00000002/00000008/art00006 |
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