Status:
COMPLETED
Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children With Severe Pneumonia in High Tuberculosis Burden Countries (TB-Speed Pneumonia)
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
UNITAID
Conditions:
Tuberculosis
Severe Pneumonia
Eligibility:
All Genders
2-59 years
Phase:
NA
Brief Summary
Despite progress in reducing tuberculosis (TB) incidence and mortality in the past 20 years, TB is a top ten cause of death in children under 5 years worldwide. However, childhood TB remains massively...
Detailed Description
Pneumonia is the leading cause of death in children under the age of 5 years worldwide. There is growing evidence that, in high TB burden settings, TB is common in children with pneumonia, with up to...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Children aged 2 to 59 months
- Newly hospitalized for severe pneumonia defined using WHO criteria as cough or difficulty in breathing with:
- Peripheral oxygen saturation \< 90% or central cyanosis, or
- Severe respiratory distress (e.g. grunting, nasal flaring, very severe chest indrawing), or
- Signs of pneumonia, defined as cough or difficulty in breathing with fast breathing (tachypnea) and/or chest indrawing, with any of the following danger signs:
- Inability to breastfeed or drink,
- Persistent vomiting
- Lethargy or reduced level of consciousness
- Convulsions,
- Stridor in calm child
- Severe malnutrition
- Informed consent signed by parent/guardian
- Exclusion criteria:
- \- Ongoing TB treatment or history of intake of anti-TB drugs in the last 6 months
Exclusion
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
2570 Patients enrolled
Trial Details
Trial ID
NCT03831906
Start Date
March 20 2019
End Date
June 30 2021
Last Update
December 4 2025
Active Locations (16)
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1
Kampong Cham Provincial Referral Hospital
Kampong Cham, Cambodia
2
National Pediatric Hospital
Phnom Penh, Cambodia
3
Takeo Provincial Referral Hospital
Takeo, Cambodia
4
Biyem Assi District Hospital
Yaoundé, Cameroon