Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children with Severe Pneumonia in High Tuberculosis Burden Countries (TB-Speed Pneumonia)

NACompletedINTERVENTIONAL
Enrollment

2,570

Participants

Timeline

Start Date

March 20, 2019

Primary Completion Date

June 30, 2021

Study Completion Date

June 30, 2021

Conditions
TuberculosisSevere PneumoniaCovid19
Interventions
DIAGNOSTIC_TEST

Xpert MTB/RIF Ultra (Ultra)

"The intervention will consist of the WHO standard of care for children with severe pneumonia plus the study intervention consisting in rapid detection of TB on the day of hospital admission using the Ultra assay performed on 1 NPA and 1 stool sample.~The sample flow will be organised to reduce time-to-results to 3 hours. Ultra will be performed at the hospital laboratory using a standard GeneXpert device, or implemented directly inward using a one-module, battery-operated GeneXpert device (G1 Edge).~Drugs will be available at the inpatient level to enable immediate initiation of TB treatment, as soon as a positive Ultra result is available."

Trial Locations (16)

Unknown

Kampong Cham Provincial Referral Hospital, Kampong Cham

National Pediatric Hospital, Phnom Penh

Takeo Provincial Referral Hospital, Takeo

Biyem Assi District Hospital, Yaoundé

Chantal Biya Foundation, Yaoundé

Angré University Teaching Hospital, Abidjan

Cocody University Teaching Hospital, Abidjan

Treichville University Teaching Hospital, Abidjan

Yopougon University Teaching Hospital, Abidjan

José Macamo General Hospital, Maputo

Maputo Central Hospital, Maputo

Jinja Regional Reference Hospital, Jinja

Mulago National Referral Hospital, Kampala

Holy Innocents Children's 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

NCT03831906 - Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children with Severe Pneumonia in High Tuberculosis Burden Countries (TB-Speed Pneumonia) | Biotech Hunter | Biotech Hunter