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Krolewiecki, Alejandro Javier
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Enbiale, Wendemagegn
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Gandasegui, Javier
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van Lieshout, Lisette
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Kepha, Stella
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Messa Junior, Augusto
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Bengtson, Michel
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Gelaye, Woyneshet
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Escola, Valdemiro
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Martinez Valladares, María
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Cambra Pellejà, María
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Algorta, Jaime
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Martí Soler, Helena
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Fleitas, Pedro
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Ballester, Maria Rosa
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Doyle, Stephen R.
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Williams, Nana Aba
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Legarda, Almudena
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Mandomando, Inacio
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Mwandawiro, Charles
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Muñoz, José
dc.date.available
2024-09-20T14:00:52Z
dc.date.issued
2022-05
dc.identifier.citation
Krolewiecki, Alejandro Javier; Enbiale, Wendemagegn; Gandasegui, Javier; van Lieshout, Lisette; Kepha, Stella; et al.; 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; Bill & Melinda Gates Foundation; Gates Open Research; 6; 5-2022; 1-13
dc.identifier.uri
http://hdl.handle.net/11336/244741
dc.description.abstract
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).
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application/pdf
dc.language.iso
eng
dc.publisher
Bill & Melinda Gates Foundation
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
ANTIHELMINTICS
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STH
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TRICHURIS TRICHIURA
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HOOKWORM
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ALBENDAZOLE
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IVERMECTIN
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Enfermedades Infecciosas
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Ciencias de la Salud
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CIENCIAS MÉDICAS Y DE LA SALUD
dc.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
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
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info:eu-repo/semantics/publishedVersion
dc.date.updated
2024-09-04T11:58:10Z
dc.identifier.eissn
2572-4754
dc.journal.volume
6
dc.journal.pagination
1-13
dc.journal.pais
Estados Unidos
dc.description.fil
Fil: Krolewiecki, Alejandro Javier. Universidad de Barcelona; España. Universidad Nacional de Salta. Sede Regional Orán. Instituto de Investigación de Enfermedades Tropicales; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Enbiale, Wendemagegn. Bahir Dar University; Etiopía. Amsterdam Institute for Infection and Immunity; Países Bajos
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Fil: Gandasegui, Javier. Universidad de Barcelona; España
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Fil: van Lieshout, Lisette. Leiden University; Países Bajos
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Fil: Kepha, Stella. Kenya Medical Research Institute; Kenia
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Fil: Messa Junior, Augusto. Centro de Investigação em Saúde de Manhiça; Mozambique
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Fil: Bengtson, Michel. Leiden University. Leiden University Medical Center.; Países Bajos
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Fil: Gelaye, Woyneshet. Bahir Dar University; Etiopía
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Fil: Escola, Valdemiro. Centro de Investigação em Saúde de Manhiça; Mozambique
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Fil: Martinez Valladares, María. Universidad de León; España. Consejo Superior de Investigaciones Científicas; España
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Fil: Cambra Pellejà, María. Universidad de León; España. Consejo Superior de Investigaciones Científicas; España
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Fil: Algorta, Jaime. Liconsa Sa; España
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Fil: Martí Soler, Helena. Universidad de Barcelona; España. Consejo Superior de Investigaciones Científicas; España
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Fil: Fleitas, Pedro. Consejo Superior de Investigaciones Científicas; España. Universidad de Barcelona; España
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Fil: Ballester, Maria Rosa. Centro de Investigación Biomédica en Red de Salud Mental; España. Institut d’Investigació Biomèdica Sant Pau; España
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Fil: Doyle, Stephen R.. Wellcome Sanger Institute; Reino Unido
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Fil: Williams, Nana Aba. Universidad de Barcelona; España. Consejo Superior de Investigaciones Científicas; España
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Fil: Legarda, Almudena. Consejo Superior de Investigaciones Científicas; España. Universidad de Barcelona; España
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Fil: Mandomando, Inacio. Centro de Investigação Em Saúde de Manhiça; Mozambique
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Fil: Mwandawiro, Charles. Eastern and Southern Africa Centre of International Parasite Control; Kenia
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Fil: Muñoz, José. Universidad de Barcelona; España. Consejo Superior de Investigaciones Científicas; España
dc.journal.title
Gates Open Research
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://gatesopenresearch.org/articles/6-62/v1
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info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.12688/gatesopenres.13615.1
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