Acceptability of levofloxacin dispersible and non-dispersible tablet formulations in children receiving TB preventive treatment
BACKGROUND: We evaluated the palatability and acceptability of a 100 mg dispersible and a non-dispersible 250 mg levofloxacin (LVX) tablet formulation in children. METHODS: Perform was a randomised, open-label, cross-over trial of the relative bioavailability of LVX dispersible vs. crushed non-dispe...
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| Format: | Article |
| Language: | English |
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International Union Against Tuberculosis and Lung Disease (The Union)
2024-02-01
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| Series: | IJTLD Open |
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| Online Access: | https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2024/00000001/00000002/art00003 |
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| author | D. T. Wademan H. R. Draper S. E. Purchase M. Palmer A. C. Hesseling L. Van der Laan A. J. Garcia-Prats |
| author_facet | D. T. Wademan H. R. Draper S. E. Purchase M. Palmer A. C. Hesseling L. Van der Laan A. J. Garcia-Prats |
| author_sort | D. T. Wademan |
| collection | DOAJ |
| description | BACKGROUND: We evaluated the palatability and acceptability of a 100 mg dispersible and a non-dispersible 250 mg levofloxacin (LVX) tablet formulation in children. METHODS: 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. RESULTS: 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). CONCLUSIONS: The dispersible LVX 100 mg tablet formulation was preferred and should be prioritised for integration into routine care. |
| format | Article |
| id | doaj-art-8c0410a768424bbca76c20c25430150f |
| institution | Kabale University |
| issn | 3005-7590 |
| language | English |
| publishDate | 2024-02-01 |
| publisher | International Union Against Tuberculosis and Lung Disease (The Union) |
| record_format | Article |
| series | IJTLD Open |
| spelling | doaj-art-8c0410a768424bbca76c20c25430150f2025-01-21T10:20:39ZengInternational Union Against Tuberculosis and Lung Disease (The Union)IJTLD Open3005-75902024-02-0112697510.5588/ijtldopen.23.04623Acceptability of levofloxacin dispersible and non-dispersible tablet formulations in children receiving TB preventive treatmentD. T. Wademan0H. R. Draper1S. E. Purchase2M. Palmer3A. C. Hesseling4L. Van der Laan5A. J. Garcia-Prats6Stellenbosch University, Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Cape Town, South Africa;Stellenbosch University, Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Cape Town, South Africa;Stellenbosch University, Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Cape Town, South Africa;Stellenbosch University, Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Cape Town, South Africa;Stellenbosch University, Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Cape Town, South Africa;Stellenbosch University, Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Cape Town, South Africa;Stellenbosch University, Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Cape Town, South Africa;BACKGROUND: We evaluated the palatability and acceptability of a 100 mg dispersible and a non-dispersible 250 mg levofloxacin (LVX) tablet formulation in children. METHODS: 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. RESULTS: 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). CONCLUSIONS: The dispersible LVX 100 mg tablet formulation was preferred and should be prioritised for integration into routine care.https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2024/00000001/00000002/art00003ltbipaediatric tbtb preventive treatmentlatent tb infectiontpt |
| spellingShingle | D. T. Wademan H. R. Draper S. E. Purchase M. Palmer A. C. Hesseling L. Van der Laan A. J. Garcia-Prats Acceptability of levofloxacin dispersible and non-dispersible tablet formulations in children receiving TB preventive treatment IJTLD Open ltbi paediatric tb tb preventive treatment latent tb infection tpt |
| title | Acceptability of levofloxacin dispersible and non-dispersible tablet formulations in children receiving TB preventive treatment |
| title_full | Acceptability of levofloxacin dispersible and non-dispersible tablet formulations in children receiving TB preventive treatment |
| title_fullStr | Acceptability of levofloxacin dispersible and non-dispersible tablet formulations in children receiving TB preventive treatment |
| title_full_unstemmed | Acceptability of levofloxacin dispersible and non-dispersible tablet formulations in children receiving TB preventive treatment |
| title_short | Acceptability of levofloxacin dispersible and non-dispersible tablet formulations in children receiving TB preventive treatment |
| title_sort | acceptability of levofloxacin dispersible and non dispersible tablet formulations in children receiving tb preventive treatment |
| topic | ltbi paediatric tb tb preventive treatment latent tb infection tpt |
| url | https://www.ingentaconnect.com/contentone/iuatld/ijtldo/2024/00000001/00000002/art00003 |
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