An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol
18 páginas, 2 tablas, 1 figura.
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| Format: | artículo biblioteca |
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Taylor & Francis
2022
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| Subjects: | Antihelmintics, STH, Trichuris trichiura, Strongyloides, Hookworm, Albendazole, Ivermectin, |
| Online Access: | http://hdl.handle.net/10261/303408 |
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dig-igm-es-10261-3034082023-03-16T12:10:05Z An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol Krolewiecki, A. Enbiale, W. Gandasegui, J. van Lieshout, L. Kepha, S. Messa Junior, A. Bengtson, M. Gelaye, W. Escola, V. Martinez Valladares, María Cambra-Pellejà, M. Algorta, J. Martí-Soler, H. Fleitas, P. Ballester, M.R. Doyle, S.R. Williams, N.A. Legarda, A. Mandomando, I. Mwandawiro, C. Muñoz, J. Antihelmintics STH Trichuris trichiura Strongyloides Hookworm Albendazole Ivermectin 18 páginas, 2 tablas, 1 figura. Background: Soil-transmitted helminths (STH) are targeted for control through mass drug-administration campaigns to prevent morbidity affecting at-risk groups in endemic regions. Although broadly successful, the use of albendazole and mebendazole achieved variable progress, with deficiencies against Trichuris trichiura and a predictable low efficacy against Strongyloides stercoralis. Novel drug combinations offer a potential solution, providing they can be delivered safely and maintain efficacy against all STH species. Here we present the protocol of a clinical trial to evaluate a fixed-dose combination (FDC) tablet containing albendazole and ivermectin that will be compared against albendazole against STH. Methods: An adaptive phase II/III randomized controlled trial will be undertaken in STH endemic sites in Ethiopia, Kenya and Mozambique to evaluate an oral FDC of 400 mg albendazole and either 9- or 18 mg ivermectin. FDC will be administered as a single dose or single doses over three-consecutive days and assessed against a single dose of 400 mg albendazole. In the phase II trial, 126 T. trichiura-infected children weighting 15 to 45 kg will be treated in a dose-escalation manner to determine safety objectives. In the phase III trial, 1097 participants aged 5 to 18 years old infected with T. trichiura, hookworm and S. stercoralis will be recruited to determine safety and efficacy. The trial will be open-label with blinded outcome assessors. Cure rate measured 21-days after-treatment in duplicate Kato-Katz is the primary efficacy outcome. Secondary objectives include efficacy evaluation by quantitative polymerase chain reaction (PCR) as an outcome measurement, description of pharmacokinetic parameters, palatability and acceptability evaluations, and monitoring of anthelmintic resistance. Conclusions: This trial with registrational goals seeks to evaluate an innovative fixed-dose combination of albendazole and ivermectin co-formulated tablets, with the goal of providing an anthelmintic regimen with improved efficacy and spectrum of coverage against STH. ClinicalTrials.gov registration: NCT05124691 (18/11/2021). 2023-03-16T12:10:04Z 2023-03-16T12:10:04Z 2022 2023-03-16T12:10:05Z artículo doi: 10.12688/gatesopenres.13615.1 issn: 2572-4754 Gates Open Research, 6: 62 (2022) http://hdl.handle.net/10261/303408 Publisher's version http://dx.doi.org/10.12688/gatesopenres.13615.1 Sí open Taylor & Francis |
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Antihelmintics STH Trichuris trichiura Strongyloides Hookworm Albendazole Ivermectin Antihelmintics STH Trichuris trichiura Strongyloides Hookworm Albendazole Ivermectin |
| spellingShingle |
Antihelmintics STH Trichuris trichiura Strongyloides Hookworm Albendazole Ivermectin Antihelmintics STH Trichuris trichiura Strongyloides Hookworm Albendazole Ivermectin Krolewiecki, A. Enbiale, W. Gandasegui, J. van Lieshout, L. Kepha, S. Messa Junior, A. Bengtson, M. Gelaye, W. Escola, V. Martinez Valladares, María Cambra-Pellejà, M. Algorta, J. Martí-Soler, H. Fleitas, P. Ballester, M.R. Doyle, S.R. Williams, N.A. Legarda, A. Mandomando, I. Mwandawiro, C. Muñoz, J. An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol |
| description |
18 páginas, 2 tablas, 1 figura. |
| format |
artículo |
| topic_facet |
Antihelmintics STH Trichuris trichiura Strongyloides Hookworm Albendazole Ivermectin |
| author |
Krolewiecki, A. Enbiale, W. Gandasegui, J. van Lieshout, L. Kepha, S. Messa Junior, A. Bengtson, M. Gelaye, W. Escola, V. Martinez Valladares, María Cambra-Pellejà, M. Algorta, J. Martí-Soler, H. Fleitas, P. Ballester, M.R. Doyle, S.R. Williams, N.A. Legarda, A. Mandomando, I. Mwandawiro, C. Muñoz, J. |
| author_facet |
Krolewiecki, A. Enbiale, W. Gandasegui, J. van Lieshout, L. Kepha, S. Messa Junior, A. Bengtson, M. Gelaye, W. Escola, V. Martinez Valladares, María Cambra-Pellejà, M. Algorta, J. Martí-Soler, H. Fleitas, P. Ballester, M.R. Doyle, S.R. Williams, N.A. Legarda, A. Mandomando, I. Mwandawiro, C. Muñoz, J. |
| author_sort |
Krolewiecki, A. |
| title |
An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol |
| title_short |
An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol |
| title_full |
An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol |
| title_fullStr |
An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol |
| title_full_unstemmed |
An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol |
| title_sort |
adaptive phase ii/iii safety and efficacy randomized controlled trial of single day or three-day fixed-dose albendazole-ivermectin co-formulation versus albendazole for the treatment of trichuris trichiura and other sth infections. alive trial protocol |
| publisher |
Taylor & Francis |
| publishDate |
2022 |
| url |
http://hdl.handle.net/10261/303408 |
| work_keys_str_mv |
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