Status:

COMPLETED

Implementation of an Integrated Care Strategy for Children Contacts of Patients With Tuberculosis

Lead Sponsor:

Corporacion para Investigaciones Biologicas

Collaborating Sponsors:

Universidad Pontificia Bolivariana

Universidad de Antioquia

Conditions:

Latent Tuberculosis

Eligibility:

All Genders

Up to 5 years

Brief Summary

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 lacki...

Detailed Description

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 th...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

July 26 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 31 2023

Estimated Enrollment :

163 Patients enrolled

Trial Details

Trial ID

NCT04331262

Start Date

July 26 2021

End Date

July 31 2023

Last Update

August 30 2023

Active Locations (1)

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Corporación para Investigaciones Biológicas

Medellín, Colombia