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Validation of a Tuberculosis Treatment Decision Algorithm in HIV-infected Children (TB-Speed HIV)

NCT04121026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2025-03-28

No results posted yet for this study

Summary

TB-Speed HIV is a prospective multicentre management study evaluating the safety and feasibility of the recently proposed PAANTHER TB treatment decision algorithm for HIV-infected children with presumptive TB. It will be conducted in four countries with high and very high TB (Tuberculosis) incidence (Côte d'Ivoire, Uganda, Mozambique, and Zambia) which have not participated in the study that developed the PAANTHER algorithm.

Conditions

Interventions

OTHER

External validation of the PAANTHER TB treatment decision algorithm

The PAANTHER algorithm will be used for a TB treatment decision by site clinicians in all children enrolled in the study. The PAANTHER algorithm and prediction score was designed as a guiding tool for empirical TB treatment decision in HIV-infected children with presumptive TB. The proposed score includes: * history of contact * suggestive TB symptoms * tachycardia * chest radiography * abdominal ultrasound * Xpert MTB/RIF Ultra. A score of \>100 is highly predictive of TB. In children with a score \>100, anti-TB treatment will be initiated immediately. In children with a score of \<100, TB treatment will not be initiated except in those with severe/life-threatening conditions for whom TB treatment decision could be made at the discretion of the site clinician. TB could be definitely ruled out after further assessment and decision made as to what treatment the children should receive in accordance with existing national protocols, along with clinical follow-up.

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Olivier Marcy, MD, PhD · University of Bordeaux, France

  • Maryline Bonnet, MD, PhD · Institut de Recherche pour le Développemnt (IRD) Montpellier, France

  • Eric Wobudeya, MD, PhD · MU-JHU Care Ltd, Kampala, Uganda

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2022-06-20
Completion
2022-06-20

Countries

  • Côte d’Ivoire
  • Mozambique
  • Uganda
  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04121026 on ClinicalTrials.gov