Table 6 Secondary endpoints

 TB diagnosis based on the clinician’s judgement

# of children diagnosed with TB based on the clinician’s judgement

Any time during the follow-up

 TB treatment initiation

Proportion of children diagnosed with TB AND who with at least one TB treatment recorded

Any time during the follow-up

 Time to TB treatment initiation

Date/Time of the 1st TB treatment – Date/Time of TB diagnosis (in hours)

Any time during the follow-up

 Duration of TB treatment at end of trial

Number of days between date of TB treatment initiation and date of TB treatment end

Any time during the follow-up (week 12 or early termination)

 Inpatient deaths

# of children who died after inclusion and before hospital discharge

Before discharge

 Duration of initial hospitalization

Date of the 1st recorded discharge – Date of the 1st recorded admission (in days)

At the first discharge

 Readmission following discharge

# of admission occurring after the 1st discharge

Any time during the follow-up

 Weight gain

Proportion of weight gain at 12 weeks (as compared to body weight at inclusion)

At 12 weeks

 Cost effectiveness

Incremental cost-effectiveness ratio (ICER) of intervention compared with WHO SOC, measured in cost per DALY averted

Lifetime, based on differences in mortality up to 12 weeks

 TB detection by NPA testing

Proportion of NPA with positive TB detection using Ultra

After 1st visit

 TB detection by Stool testing

Proportion of stool samples with positive TB detection using Ultra

After 1st visit

 TB detection by NPA and Stool testing

Proportion of samples (NPA and/or stool) with positive TB detection using Ultra

After 1st visit

 Turnaround time between NPA collection and result of Ultra

Date/Time of Ultra results – Date/Time of NPA collection

After 1st visit

 Turnaround time between stool sample collection and result of Ultra

Date/Time of Ultra results – Date/Time of stool sample collection

After 1st visit

 NPA collected as per protocol

Proportion of children with NPA collected as per protocol

At 1st visit

 Stool samples collected as per protocol

Proportion of children with stool samples collected as per protocol

At 1st visit

 Safety: adverse events (AEs) during NPA collection

Number of adverse events collected by study nurses during NPA collection including as vomiting, nose bleeding, low oxygen saturation

Any time during the follow-up

 Tolerability: discomfort/pain/distress experienced by the child during NPA collection procedure

Assessed by the child him/herself (Wong-Baker face scale), by the parents (visual analog scale), by the nurses (FLACC behavioural scale)

At NPA collection time