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Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent Mycobacterium tuberculosis infection with Isoniazid in the 300 mg formulation

INTRODUCTION: It is essential to strengthen the treatment of latent tuberculosis infection (LTBI) to break the chain of transmission. The drug used worldwide for the treatment of LTBI is Isoniazid. A clinical trial conducted in Brazil has demonstrated the bioequivalence of Isoniazid in the 300 mg fo...

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Autores principales: Cola, João Paulo, do Prado, Thiago Nascimento, Campos, Bárbara Almeida, Borges, Bárbara Juliana Pinheiro, Alves, Bárbara Manuella Cardoso Sodré, de Jezus, Sonia Vivian, Sales, Carolina Maia Martins, de Araújo, Wildo Navegantes, Tavares, Noemia Urruth Leão, Noia Maciel, Ethel Leonor
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9942980/
https://www.ncbi.nlm.nih.gov/pubmed/36802383
http://dx.doi.org/10.1371/journal.pone.0281638
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author Cola, João Paulo
do Prado, Thiago Nascimento
Campos, Bárbara Almeida
Borges, Bárbara Juliana Pinheiro
Alves, Bárbara Manuella Cardoso Sodré
de Jezus, Sonia Vivian
Sales, Carolina Maia Martins
de Araújo, Wildo Navegantes
Tavares, Noemia Urruth Leão
Noia Maciel, Ethel Leonor
author_facet Cola, João Paulo
do Prado, Thiago Nascimento
Campos, Bárbara Almeida
Borges, Bárbara Juliana Pinheiro
Alves, Bárbara Manuella Cardoso Sodré
de Jezus, Sonia Vivian
Sales, Carolina Maia Martins
de Araújo, Wildo Navegantes
Tavares, Noemia Urruth Leão
Noia Maciel, Ethel Leonor
author_sort Cola, João Paulo
collection PubMed
description INTRODUCTION: It is essential to strengthen the treatment of latent tuberculosis infection (LTBI) to break the chain of transmission. The drug used worldwide for the treatment of LTBI is Isoniazid. A clinical trial conducted in Brazil has demonstrated the bioequivalence of Isoniazid in the 300 mg formulation with 3 tablets in the 100 mg formulation. Further studies are needed to evaluate the completion of treatment with Isoniazid 300 mg single tablet. OBJECTIVE: Describing a protocol for a clinical trial to evaluate the completion of treatment of LTBI with the drug Isoniazid in 300 mg tablet formulation compared to the use of Isoniazid in 100 mg tablet formulation. METHODS: This is a pragmatic, multicenter, randomized, open-label clinical trial registered on the Rebec RBR-2wsdt6 platform. Individuals 18 years of age or older with an indication for treatment of LTBI will be included, with only 1 individual per family nucleus. Individuals whose index case of active TB is categorized as retreatment, multidrug-resistant and extremely resistant, individuals transferred from the original center two or more weeks after the onset of treatment, and persons deprived of liberty will be excluded. The study intervention will be the treatment of LTBI with 1 tablet of Isoniazid 300 mg. The control group will receive the treatment of LTBI with 3 tablets of Isoniazid 100 mg. Follow-up will be performed at month 1, month 2 and at the end of treatment. The primary outcome will be completion of treatment. CONCLUSION: It is expected that with the treatment with the 300 mg formulation, more patients will complete the treatment based on the complexity index of pharmacotherapy. Our study intends to substantiate theoretical and operational strategies that respond to the demand for incorporation of a new formulation of the drug for the treatment of LTBI in the Unified Health System network.
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spelling pubmed-99429802023-02-22 Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent Mycobacterium tuberculosis infection with Isoniazid in the 300 mg formulation Cola, João Paulo do Prado, Thiago Nascimento Campos, Bárbara Almeida Borges, Bárbara Juliana Pinheiro Alves, Bárbara Manuella Cardoso Sodré de Jezus, Sonia Vivian Sales, Carolina Maia Martins de Araújo, Wildo Navegantes Tavares, Noemia Urruth Leão Noia Maciel, Ethel Leonor PLoS One Study Protocol INTRODUCTION: It is essential to strengthen the treatment of latent tuberculosis infection (LTBI) to break the chain of transmission. The drug used worldwide for the treatment of LTBI is Isoniazid. A clinical trial conducted in Brazil has demonstrated the bioequivalence of Isoniazid in the 300 mg formulation with 3 tablets in the 100 mg formulation. Further studies are needed to evaluate the completion of treatment with Isoniazid 300 mg single tablet. OBJECTIVE: Describing a protocol for a clinical trial to evaluate the completion of treatment of LTBI with the drug Isoniazid in 300 mg tablet formulation compared to the use of Isoniazid in 100 mg tablet formulation. METHODS: This is a pragmatic, multicenter, randomized, open-label clinical trial registered on the Rebec RBR-2wsdt6 platform. Individuals 18 years of age or older with an indication for treatment of LTBI will be included, with only 1 individual per family nucleus. Individuals whose index case of active TB is categorized as retreatment, multidrug-resistant and extremely resistant, individuals transferred from the original center two or more weeks after the onset of treatment, and persons deprived of liberty will be excluded. The study intervention will be the treatment of LTBI with 1 tablet of Isoniazid 300 mg. The control group will receive the treatment of LTBI with 3 tablets of Isoniazid 100 mg. Follow-up will be performed at month 1, month 2 and at the end of treatment. The primary outcome will be completion of treatment. CONCLUSION: It is expected that with the treatment with the 300 mg formulation, more patients will complete the treatment based on the complexity index of pharmacotherapy. Our study intends to substantiate theoretical and operational strategies that respond to the demand for incorporation of a new formulation of the drug for the treatment of LTBI in the Unified Health System network. Public Library of Science 2023-02-21 /pmc/articles/PMC9942980/ /pubmed/36802383 http://dx.doi.org/10.1371/journal.pone.0281638 Text en © 2023 Cola et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Study Protocol
Cola, João Paulo
do Prado, Thiago Nascimento
Campos, Bárbara Almeida
Borges, Bárbara Juliana Pinheiro
Alves, Bárbara Manuella Cardoso Sodré
de Jezus, Sonia Vivian
Sales, Carolina Maia Martins
de Araújo, Wildo Navegantes
Tavares, Noemia Urruth Leão
Noia Maciel, Ethel Leonor
Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent Mycobacterium tuberculosis infection with Isoniazid in the 300 mg formulation
title Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent Mycobacterium tuberculosis infection with Isoniazid in the 300 mg formulation
title_full Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent Mycobacterium tuberculosis infection with Isoniazid in the 300 mg formulation
title_fullStr Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent Mycobacterium tuberculosis infection with Isoniazid in the 300 mg formulation
title_full_unstemmed Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent Mycobacterium tuberculosis infection with Isoniazid in the 300 mg formulation
title_short Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent Mycobacterium tuberculosis infection with Isoniazid in the 300 mg formulation
title_sort protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of latent mycobacterium tuberculosis infection with isoniazid in the 300 mg formulation
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9942980/
https://www.ncbi.nlm.nih.gov/pubmed/36802383
http://dx.doi.org/10.1371/journal.pone.0281638
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