Study protocol: infectious diseases consortium (I3D) for study on integrated and innovative approaches for management of respiratory infections: respiratory infections research and outcome study (RESPIRO)

Table 1 Summary of study schedule

Study activity	Screening	Inpatient follow-up^a		Samples, symptoms questionnaire, and quality-of-life survey			Final visit
Study activity	D1 (priority)	Every other day (D3-15) ± 1 day	D21 ± 7 days	D28 ± 14 days (priority)	D90 ± 30 days (priority)	D180 ± 60 days	D360 ± 90 days
Eligibility assessment	X
Informed consent	X
Demographics	X
Medical history	X
Clinical data collection	X	Daily until end of hospital stay		X	X	X	X
Symptoms questionnaire	X	Every other day until end of hospital stay. (Day 1 to 7 of study will be prioritised.)		X	X	X	X
Quality-of-life survey				X	X	X	X
Sample collection^b
Blood^c	X	X	X	X	X	X	X
Respiratory samples	X	X	X	X	X	X	X
Urine^c	X	X	X	X	X	X	X
Stool^c	X	X	X	X	X	X	X
Rarely other biological samples (e.g. tears)	X	X	X	X	X	X	X
Residual samples^d	X

^aSerial sampling will stop when the patient’s acute illness resolves, or when they are discharged from the hospital: next samples taken will be at 28, 90, 180, 360 days post-recruitment
^bIn the event of resource limitations requiring sampling frequency to decrease or for any other reasons (e.g. the patient’s personal preference to have minimal sampling for research purposes), samples will be prioritised at recruitment, day 28, and day 90
^cUp to a maximum of 30 mL (approximately 6 teaspoons) of blood may be drawn for each time point as well as 10 mL of urine and 10 g of stool (approximately 2 teaspoons)
^dResidual samples are leftover samples from routine clinical testing. The study team will coordinate with the clinical laboratory team to keep any residual samples that may be useful to this study

ISSN: 1471-2334