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COMPLETED
NCT04121026
NA

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

Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

View on ClinicalTrials.gov

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.

Official title: Validation of a Tuberculosis Treatment Decision Algorithm in HIV-infected Children

Key Details

Gender

All

Age Range

1 Month - 14 Years

Study Type

INTERVENTIONAL

Enrollment

278

Start Date

2019-10-02

Completion Date

2022-06-20

Last Updated

2026-09-24

Healthy Volunteers

No

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.

Locations (7)

Cocody University Teaching Hospital

Abidjan, Côte d’Ivoire

Treichville University Teaching Hospital

Abidjan, Côte d’Ivoire

José Macamo General Hospital

Maputo, Mozambique

Maputo Central Hospital

Maputo, Mozambique

Mbarara Regional Hospital

Mbarara, Uganda

Lusaka University Teaching Hospital

Lusaka, Zambia

Arthur Davidson Children Hospital

Ndola, Zambia