Number of children diagnosed with TB at 12 weeks
• Number of children diagnosed with TB at 12 weeks:
based on Ultra results
based on the clinician's judgement
• Proportion of children with TB treatment initiated at any time during follow-up
• Time to TB treatment initiation
• Duration of TB treatment at end of trial
• Duration of TB treatment at end of trial, i.e. week 12 or early termination
• Number of inpatient deaths
• Duration of initial hospitalization
• Number of readmissions following discharge
• Weight gain at 12 weeks
• Weight gain at 12 weeks, as compared to body weight at inclusion
• Proportion of NPA and stool samples with positive TB detection using Ultra•
In the intervention arm only.
• Proportion of Ultra-confirmed and clinically-diagnosed TB cases
In the intervention arm only.
• Feasibility of NPA and stool samples collection (1)
In the intervention arm only. Proportion of children with samples collected as per protocol
• Feasibility of NPA and stool samples collection (2)
In the intervention arm only. Turnaround time between NPA or stool sample collection and result of Ultra
• Safety of NPA collection
In the intervention arm only. Adverse events collected by study nurses during NPA collection such as vomiting, nose bleeding, low oxygen saturation
• Tolerability of NPA specimen collection procedures assessed by the child
In the intervention arm only. Discomfort/pain/distress experienced by the child assessed by the child him/herself (Wong-Baker face scale)
• Tolerability of NPA specimen collection procedures assessed by the parents
In the intervention arm only. Discomfort/pain/distress experienced by the child assessed by the parents (visual analog scale)
• Tolerability of NPA specimen collection procedures assessed by the nurses
In the intervention arm only. Discomfort/pain/distress experienced by the child assessed by the nurses (FLACC behavioural scale)
• Acceptability of NPA and stool specimen collection procedures
In the intervention arm only.
• Acceptability of NPA and stool specimen collection procedures assessed by parents and nurses (semi-structured interviews and auto-questionnaires).
To assess the prevalence of Covid-19 (confirmed and probable cases) in children below 5 years admitted with WHO-defined severe pneumonia
Number of inpatients death in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Duration of initial hospitalization in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Number of readmissions following discharge in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Weight gain in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Inability to breastfeed or drink in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Inability to breastfeed or drink in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Inability to breastfeed or drink in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Lethargy or reduced level of consciousness in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Lethargy or reduced level of consciousness in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Lethargy or reduced level of consciousness in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Convulsions in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Convulsions in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Convulsions in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Stridor in calm child in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Stridor in calm child in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Stridor in calm child in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Oxygen saturation < 90% in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Oxygen saturation < 90% in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Oxygen saturation < 90% in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Central cyanosis in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Central cyanosis in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Central cyanosis in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Grunting in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Grunting in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Grunting in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Nasal flaring in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Nasal flaring in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Nasal flaring in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Chest in-drawing in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Chest in-drawing in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
Chest in-drawing in children with severe pneumonia (infected with SARS-CoV-2 versus to uninfected children)
To describe the laboratory characteristics (CRP) of Covid-19 cases
To describe the laboratory characteristics (full blood count) of Covid-19 cases
Description by type and frequency of the signs of viral pneumonia on CXR with interstitial changes of Covid-19 cases
To assess the yield of stool as compared to nasal swab for the detection of the SARS-CoV-2 by real time reverse transcription-polymerase chain reaction (RT-PCR)
Number of children having a PCR positive for respiratory syncytial virus
PCR detection of respiratory syncytial virus
To assess seroprevalence and seroconversion (immunoglobulin M and immunoglobulin G to SARS-CoV-2) at Day 0 and Month 3