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临床试验/NCT04331262
NCT04331262已完成不适用

Tuberculosis en Niños: Implementación de Una Estrategia de Cuidado Integral Para Los Niños Contacto de Pacientes Con Tuberculosis Pulmonar Bacilífera

Corporacion para Investigaciones Biologicas1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2021年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
163
试验地点
1
主要终点
Treatment Compliance

研究概览

简要总结

Introduction: childhood tuberculosis continues to be a major public health problem, despite the fact that the visibility of the epidemic in this population group has increased, studies are still lacking that can resolve the gaps that persist.

Objective: To design, implement and evaluate an integrated care strategy for children under five years old household contacts of patients with smear positive pulmonary tuberculosis in Medellín and the Metropolitan Area.

Methodology: quasi-experimental study, in which around 300 children household contacts of patients with smear positive pulmonary tuberculosis from Medellín and the Metropolitan Area will be evaluated, who will be recruited in a period of one year. A subgroup of these children, estimated at 85, who require treatment for latent tuberculosis, will be offered to receive treatment for latent tuberculosis under a integrated care strategy that includes some modifications to the currently standardized scheme in Colombia, with rifampicin treatment daily oral route for four months, follow-up under the project scheme with the availability of a nurse, general practitioner, specialists, care by professionals from other disciplines such as social work, psychology, and nutritionist, and the provision of incentives (transport and food assistance). This strategy will be compared with isoniazid treatment according to the standardized scheme in the country, which was received by a cohort of children between 2015 and 2018. The study has the CIB Research Ethics Committee approval.

Expected results: this project is expected to contribute with greater local evidence of integrated care strategies that allow greater compliance with treatment for latent tuberculosis in children, so that there is a real impact in the control of childhood tuberculosis and in the reduction of tuberculosis reservoirs in order to achieve the goals proposed by the World Health Organization's End TB Strategy.

详细描述

Objective:

To design, implement and evaluate an integrated care strategy for children under five years old household contacts of patients with smear positive pulmonary tuberculosis in Medellín and the Metropolitan Area.

Methodology:

Study design

Quasi-experimental study with a one-year follow-up, which will include a cohort of children household contacts of patients with smear positive pulmonary TB from Medellín and the Valle de Aburrá Metropolitan Area, to carry out the contact tracing and treatment for latent TB in those who is indicated, and who will receive the intervention of the integrated care strategy. Compliance with the treatment achieved with this strategy will be compared with compliance achieved with the treatment with isoniazid in the 2015-2018 cohort.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for initial evaluation (clinical and paraclinical)
  • Child under five years of age.
  • Household contact of smear positive confirmed pulmonary tuberculosis patient.
  • That the parents or legal guardian sign the informed consent.
  • To live in Medellín or the Metropolitan Area of the Aburrá Valley.
  • Diagnostic criteria for latent tuberculosis
  • Asymptomatic child.
  • Normal clinical assessment, without clinical signs of active TB.
  • Normal chest x-ray.
  • Response to the tuberculin skin test (TST) ≥5 mm and / IGRA (QuantiFERON®-TB Gold Plus - QFT Plus) positive.
  • Inclusion criteria to start treatment for latent tuberculosis infection
  • Having a diagnosis of latent tuberculosis or
  • Being in immunological window period.

排除标准

  • Exclusion criteria for receiving treatment for latent tuberculosis
  • Having symptoms or signs of active TB and that the disease has not been ruled out.
  • Having basic liver disorder.
  • Exclusion criteria for performing induced sputum
  • Having severe asthma.

结局指标

主要结局

Treatment Compliance

时间窗: 4 months

Proportion of treatment compliance

次要结局

未报告次要终点

研究者

发起方
Corporacion para Investigaciones Biologicas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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