Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children with Severe Pneumonia in High Tuberculosis Burden Countries
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 underreported and undiagnosed, mostly because of the challenges in confirming its diagnosis due to the paucibacillary nature of the disease and the difficulty in obtaining expectorated sputum in children.

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 23% of those admitted to hospital with an initial diagnosis of pneumonia later being diagnosed as TB. However, the current World Health Organization (WHO) standard of care (SOC) for young children with pneumonia considers a diagnosis of TB only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. Hence, TB is often under-diagnosed or diagnosed late in children presenting with pneumonia.

In this context, the investigators are proposing to assess the impact on mortality of adding the systematic early detection of TB using Xpert MTB/RIF Ultra, performed on NPAs and stool samples, to the WHO SOC for children with severe pneumonia, followed by immediate initiation of anti-TB treatment in children testing positive on any of the samples.

TB-Speed Pneumonia is a multicentric, stepped wedge diagnostic trial conducted in six countries with high TB incidence: Cote d'Ivoire, Cameroon, Uganda, Mozambique, Zambia and Cambodia.

The sub-study on Covid-19 will assess the prevalence and impact of the Covid-19 in young children hospitalized with severe pneumonia. The sub-study findings are expected to guide policy makers and clinicians on potential specific screening and management measures for these vulnerable groups of children. They are also key to analysing TB-Speed Pneumonia results on mortality in a context of the Covid-19 outbreak and to take into consideration SARS-CoV-2 infection status in the main study analysis.


Options:
A: Intervention Type: OTHER; Name: Development of a diagnosis algorithm; Assigned to Arm(s): N/A
B: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Interventional; Type: EXPERIMENTAL; Interventions: Diagnostic Test: Xpert MTB/RIF Ultra (Ultra) | Intervention Type: DIAGNOSTIC_TEST; Name: Xpert MTB/RIF Ultra (Ultra); Assigned to Arm(s): Interventional
C: Arm Label: Facility-based screening; Type: EXPERIMENTAL; Interventions: Other: Active TB case finding | Arm Label: Contact screening; Type: EXPERIMENTAL; Interventions: Other: Active TB case finding | Intervention Type: OTHER; Name: Active TB case finding; Assigned to Arm(s): Contact screening, Facility-based screening
D: Arm Label: 0.1 µg C-Tb; Type: EXPERIMENTAL; Interventions: Biological: C-Tb | Arm Label: 2 T.U Tuberculin PPD RT 23 SSI; Type: ACTIVE_COMPARATOR; Interventions: Biological: Tuberculin PPD RT 23 SSI | Arm Label: 0.1 µg C-Tb / 2 T.U Tuberculin PPD; Type: EXPERIMENTAL; Interventions: Biological: C-Tb / Tuberculin PPD RT 23 SSI | Intervention Type: BIOLOGICAL; Name: C-Tb; Assigned to Arm(s): 0.1 µg C-Tb | Intervention Type: BIOLOGICAL; Name: Tuberculin PPD RT 23 SSI; Assigned to Arm(s): 2 T.U Tuberculin PPD RT 23 SSI | Intervention Type: BIOLOGICAL; Name: C-Tb / Tuberculin PPD RT 23 SSI; Assigned to Arm(s): 0.1 µg C-Tb / 2 T.U Tuberculin PPD

Answer: B