Table 1.
Study Characteristics of the Randomized Controlled Trials Analyzed Using Desirability of Outcome Ranking
Characteristic | ZEPHyR | VITAL |
---|---|---|
No. of participants in mITT populationa | 448 | 718 |
Study design | Phase 4, multicenter, double-blind RCT | Phase 3, multicenter, double-blind, double-dummy RCT |
Study population | Hospital-acquired or healthcare-associated MRSA pneumonia | Ventilated hospital-acquired or ventilator-associated gram-positive pneumonia |
Dates of enrollment | Oct 2004–Jan 2010 | Jun 2014–Jun 2018 |
Study drugs | Vancomycin vs linezolid | Linezolid vs tedizolid |
Duration of therapy | 7–14 d | 7 d tedizolid; 10 d linezolid |
Original primary endpoint | Clinical outcome at end of study | Clinical outcome at TOC and 28-d all-cause morality |
Test of cureb | EOT + 7–30 d | EOT + 7–14 d |
Time frame for monitoring adverse events, d | EOT + 7–30b (∼days 14–44) | Days 28–32 |
Abbreviations: EOT, end of therapy; mITT, modified intention to treat; MRSA, methicillin-resistant Staphylococcus aureus; RCT, randomized controlled trial; TOC, test of cure.
amITT was defined as all randomized patients who received ≥1 dose of study drug.
bIn ZEPHyR, this was labeled the end of study visit.