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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
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
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