CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,106 enrolled
Drug / intervention
Decentralization of Childhood TB Diagnosisother
Likely dose
Not stated in record
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Search/NCT04038632
NCT04038632N/ACompleted

Impact of an Innovative Childhood TB Diagnostic Approach Decentralized to District Hospital and Primary Health Care Levels on Childhood Tuberculosis Case Detection and Management in High Tuberculosis Incidence Countries

Institut National de la Santé Et de la Recherche Médicale, France·interventional·Posted Jul 31, 2019·Updated Mar 26, 2025

In Brief

A clinical study evaluating Decentralization of Childhood TB Diagnosis for Tuberculosis in Children. Completed, enrolled 3,106 participants across 59 sites in 6 countries.

Detailed Summary

The TB-Speed Decentralisation study aims to increase childhood Tuberculosis (TB) case detection at district hospital (DH) and Primary health Care (PHC) levels using adapted and child-friendly specimen collection methods, i.e. Nasopharyngeal Aspirate (NPA) and stool samples, sensitive microbiological detection tests (Ultra) close to the point-of-care (Omni/G1(Edge)), reinforced training on clinical diagnosis, and standardized CXR quality and interpretation using digital radiography. The TB-Speed Decentralisation study will evaluate the impact of an innovative patient care level diagnostic approach deployed at DH and PHC levels, namely the DH focused and the PHC focused decentralization strategies. This is aimed at, improving case detection in 6 high TB incidence in low/moderate resource countries: Cambodia, Cameroon, Côte d'Ivoire, Mozambique, Sierra Leone, and Uganda, and compare effectiveness and cost-effectiveness of the two different decentralization approaches. The hypothesis is that, in countries with high and very high TB incidence (100-299 and ≥300 cases/100,000 population/year, respectively), a systematic approach to the screening for and diagnosis of TB in sick children presenting to the health system will increase childhood TB case detection, especially PTB, which represents the majority of the disease burden (\>75% of case). The study also hypothesizes that sputum collection using battery-operated suction machines and microbiological TB diagnosis using Omni/G1 (Edge) can be decentralized to PHC level, thus enabling TB diagnosis and treatment in children at PHC level.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCambodia, Cameroon, Côte d’Ivoire, Mozambique, Sierra Leone, Uganda
CollaboratorsUNITAID

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 31, 2019
Enrollment StartMar 7, 2020
Primary CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.9 years ago

Interventions

Decentralization of Childhood TB Diagnosisother

The patient care level TB diagnostic approach consists of systematic TB screening, clinical evaluation, NPA and stool or sputum testing using Xpert Ultra, and optimised CXR reading will be implemented at DH and PHC levels