Table 5.
Follow-Up Schedule and Sample and Data Collection for Seta Participants
| Enrolment of eligible patients | Follow-up of Study participants | Follow-up Scheduleb | ||||||
|---|---|---|---|---|---|---|---|---|
| Day 0a | Day 3–7c | Day 12–14 | Day 28–30 | Day 90 | Day 180 | Day 270 | Day 365 | |
| Blood Stool OPSd Urine LT-SES (QoL only)e |
Salmonella cases/ special cases |
Blood Stool OPS (only iNTS case) LT-SES COIf COOIf |
...
... ... LT-SES COI COOI |
Blood Stool OPS (only iNTS case) LT-SES COI COOI |
Blood Stool OPS (only iNTS case) LT-SES COI COOI |
Blood Stool OPS (only iNTS case) LT-SES ... ... |
...
... ... LT-SES .. ... |
Blood Stool OPS (only iNTS case) LT-SES ... ... |
| Neighborhood controls (NCs)g | Enrolment | Follow-uph | ||||||
| Blood Stool OPS (only iNTS associated) |
...
... ... |
...
... ... |
...
... ... |
Blood Stool OPS (only iNTS associated) |
...
... ... |
Blood Stool OPS (only iNTS associated) |
||
| LT-SES COOIf |
LT-SES COOIf |
LT-SES COOIf |
LT-SES COOIf |
LT-SES
... |
...
... |
LT-SES
... |
||
| Household contacts (HCs)g | Enrolment | Follow-uph | ||||||
|
Blood Stool OPS (only iNTS associated) |
...
... ... |
...
... ... |
...
... ... |
Blood Stool OPS (only iNTS associated) |
...
... ... |
Blood Stool OPS (only iNTS associated) |
||
| Clinical cases (CCs)i | COIf | COIf | COIf | COIf | ... | ... | ... | |
Abbreviations: COI, cost of illness; COOI, Cost of other illness; LT-SES, long-term socioeconomic study; iNTS, invasive nontyphoidal Salmonella; OPS, oropharyngeal swab; QoL, Quality-of-Life.
aDay 0: Enrolment date of the SETA study-eligible patients who meet the study inclusion criteria (See Table 3).
bClinical follow-up visits for cases: visit 1 (Day 3–7 or as soon as blood culture confirmation), visit 2 (days 28–30), visit 3 (day 90), visit 4 (day 180), and visit 5 (day 365) with a window period of +7 days (or longer as appropriate to address challenges in the respective study field settings).
cDay 3–7: Date when blood culture result is known. This time point may not be strictly limited as scheduled.
dOPS collection at enrolment and for only iNTS cases and the corresponding matched neighborhood controls (NCs) and household contacts (HCs). Country-specific adjustments may be further applied.
eLT-SES and COI surveys are performed in parallel to the clinical follow-up visits of cases and NCs, with additional follow-up time points (days 12–14 and day 270). LT-SES: Quality-of-Life (QoL) and Long-term Socio-Economic Study surveys.
fCOI & COOI stops when self-reported illness ends. Only S. typhi cases, special cases and NCs receive COOI.
gEnrolment of NCs and HCs are recommended during the first follow-up visit of the corresponding cases, which is day 3–7 or as soon as blood culture confirmation of cases.
hClinical follow-up visits for NCs and HCs after enrolment: visit 1 (day 180) and visit 2 (day 365).
iClinical cases (CCs): Clinical cases are laboratory negative but clinical suspected typhoid fever cases. CCs are matched with S. Typhi cases and special cases.