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. 2023 Oct 31;79(4):871–887. doi: 10.1093/cid/ciad666

Table 7.

Primary and Secondary Endpoints for the EOS Domain

Endpoint Endpoint Measure
Primary All-cause mortality 90 d after platform entry.
Secondary
  • 1. Number of days of IV antibiotic therapy in the total index hospitalization (which includes OPAT), starting from platform entry, for those surviving until hospital discharge

  • 2. Number of days alive and free of antibiotics by Day 42 from platform entry

    • (a) For all antibiotics

    • (b) For IV antibiotics

  • 3. Peripherally inserted central catheter (PICC)/other central venous catheter complications requiring line removal, during the total index hospitalisation (which includes OPAT), starting from platform entry

    • (a) This outcome will be collected at total index hospital/OPAT discharge as a Y/N question. It will include any of the following: catheter-related blood stream infection; exit site infection; catheter-related superficial or deep venous thrombosis/thrombophlebitis, catheter blockage. It will NOT include PICC line rupture, leakage, displacement, or splitting unless it results in or occurs in addition to one of the above events.

  • 4. Clinician-initiated change in treatment strategy from allocated EOS domain intervention (eg, changed to IV antibiotics when allocated to oral antibiotics or vice versa) from reveal of EOS allocation until platform day 28 due to an adverse event deemed by the treating doctor/team to be of sufficient severity to change strategy.

  • 5. Clinician-initiated change in treatment strategy from allocated EOS domain intervention (eg, changed to IV antibiotics when allocated to oral antibiotics or vice versa) from reveal of EOS allocation until platform day 28 due to presumed lack of efficacy of strategy according to the treating doctor/team.

Abbreviations: EOS, early oral switch; IV, intravenous; OPAT, outpatient antibiotic treatment; N, no; Y, yes.