评价 300 毫克规格异烟肼治疗潜伏性结核分枝杆菌感染治疗完成情况的实用型随机临床试验方案。

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

机构信息

Postgraduate Program in Collective Health, Laboratory of Epidemiology, Universidade Federal do Espírito Santo, Vitória, Espírito Santo, Brazil.

Postgraduate Program in Pharmaceutical Sciences, Universidade de Brasília, Brasília, Distrito Federal, Brazil.

出版信息

PLoS One. 2023 Feb 21;18(2):e0281638. doi: 10.1371/journal.pone.0281638. eCollection 2023.

DOI:10.1371/journal.pone.0281638

PMID:36802383

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9942980/

Abstract

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.

摘要

简介

加强潜伏性结核感染（LTBI）的治疗对于打破传播链至关重要。全球用于治疗 LTBI 的药物是异烟肼。巴西进行的一项临床试验证明了 300 毫克制剂的异烟肼与 100 毫克制剂的 3 片在生物等效性方面是等效的。需要进一步的研究来评估用 300 毫克单一片剂异烟肼完成治疗的情况。

目的

描述一项临床试验方案，以评估用 300 毫克片剂异烟肼药物治疗 LTBI 的完成情况，与使用 100 毫克片剂异烟肼的情况进行比较。

方法

这是一项实用的、多中心、随机、开放性临床试验，在 Rebec RBR-2wsdt6 平台上注册。将纳入年龄在 18 岁或以上且有 LTBI 治疗指征的个体，每个家庭核心只有 1 人。活动性结核病的索引病例被归类为复治、耐多药和极端耐药、在治疗开始后两周或以上从原中心转来的个体以及被剥夺自由的个体将被排除在外。研究干预措施将是用 1 片 300 毫克异烟肼治疗 LTBI。对照组将用 3 片 100 毫克异烟肼治疗 LTBI。将在第 1 个月、第 2 个月和治疗结束时进行随访。主要结局将是完成治疗。