臨床研究等提出・公開システム

Staphylococcus aureus Network Adaptive Platform trial (SNAP)

Staphylococcus aureus Network Adaptive Platform trial (SNAP)

Gu Yoshiaki

Institute of Science Tokyo Hospital

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan 113-8519

yogu.cid@tmd.ac.jp

Okamoto Koh

Institute of Science Tokyo Hospital

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan 113-8519

+81-3-3813-6111

snapjapan_2024@ml.tmd.ac.jp

Recruiting

Oct. 21, 2024

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1. Staphylococcus aureus complex grown from more than 1 blood culture
2. Admitted to participating hospital at anticipated time of eligibility assessment

1. Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture
2. Polymicrobial bacteraemia, defined as more than one organism (at species level) in the index blood cultures OR in any subsequent blood culture reported between the collection of the index blood culture and platform eligibility assessment, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician
3. Known previous participation in the randomised SNAP platform
4. Known positive blood culture for S. aureus (of the same silo: PSSA, MSSA or MRSA) between 72 hours and 180 days prior to the time of eligibility assessment
5. Treating team deems enrolment in the study is not in the best interest of the patient
6. Treating clinician believes that death is imminent and inevitable
7. Patient is for end-of-life care and antibiotic treatment is considered not appropriate
8. Patient <18 years of age and paediatric recruitment not approved at recruiting site
9. Patient has died since the collection of the index blood culture

Both

Staphylococcus aureus Bacteraemia

the SNAP trial will examine multiple different treatment options at once.

D013211

All-cause mortality 90 days after platform entry.

A core set of secondary endpoints will be evaluated in each domain:
1. All cause mortality at 14, 28 and 42 days after platform entry
2. Duration of survival censored at 90 days after platform entry
3. Length of stay of acute index inpatient hospitalisation for those surviving until discharge from acute inpatient facilities (excluding HITH/COPAT/OPAT/rehab), measured from platform entry to discharge from acute inpatient facilities, truncated at 90 days after platform entry
4. Length of stay of total index hospitalisation for those surviving until hospital discharge (including HITH/COPAT/OPAT/rehab), measured from platform entry to discharge from total index hospitalisation, truncated at 90 days after platform entry
5. Time to being discharged alive from the total index hospitalisation (including HITH/COPAT/OPAT/rehab), measured from platform entry to discharge from total index hospitalisation, truncated at 90 days after platform entry (and all deaths within 90 days will be considered 90 days)
6. Microbiological treatment failure (Positive sterile site culture for S. aureus (of the same silo as the index isolate) between 14 and 90 days after platform entry)
7. Diagnosis of new foci between 14 and 90 days after platform entry. The presence of new foci will be determined by the site investigator and can incorporate clinical, radiological, microbiological and pathological findings.
8. C. difficile diarrhea as determined by a clinical laboratory in the 90 days following platform entry for participants more than 2 years of age
9. Serious adverse reactions in the 90 days following platform entry
10. Health economic costs as detailed in the health economics appendix
11. Proportion of participants who have returned to their usual level of function at day 90 as determined by whether the modified functional bloodstream infection score (FBIS) remained the same or improved between baseline and 90 days after platform entry
12. Desirability of outcome ranking 1 (modified Antibiotic Resistance Leadership Group version) at 90 days after platform entry
13. Desirability of outcome ranking 2 (SNAP version) at 90 days after platform entry
14. Total number of antibiotic days (IV and/or oral) in the 90 days following platform entry
15. Days alive and free of antibiotics in the 90 days following platform entry

+81-3-5803-4574

Sept. 05, 2024

No

Australia/Canada/New Zealand/Singapore/United Kingdom