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

NACompletedINTERVENTIONAL
Enrollment

278

Participants

Timeline

Start Date

October 2, 2019

Primary Completion Date

June 20, 2022

Study Completion Date

June 20, 2022

Conditions
TuberculosisHIV
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."

Trial Locations (7)

Unknown

Cocody University Teaching Hospital, Abidjan

Treichville University Teaching Hospital, Abidjan

José Macamo General Hospital, Maputo

Maputo Central Hospital, Maputo

Mbarara Regional Hospital, Mbarara

Lusaka University Teaching Hospital, Lusaka

Arthur Davidson Children Hospital, Ndola

All Listed Sponsors
collaborator

UNITAID

OTHER

lead

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

OTHER_GOV

NCT04121026 - Validation of a Tuberculosis Treatment Decision Algorithm in HIV-infected Children (TB-Speed HIV) | Biotech Hunter | Biotech Hunter