TABLE 3.
Summary of currently active registered clinical trials studying oritavancin or dalbavancina
| Drug and trial identifier | n | Infection(s) | Design | Dosing | Comparator | Primary outcome | Status | Comments |
|---|---|---|---|---|---|---|---|---|
| Oritavancin | ||||||||
| NCT03761953 | 15 | S. aureus bacteremia with or without IE | Single-center, open-label, pilot study | 1,200 mg onceb | None | Relapse at 6 wk | Recruiting | Focused on opioid users, requires prove of negative blood cultures |
| Dalbavancin | ||||||||
| NCT03982030 | 24 | Bacteremia, right-sided IE, BJIs | Phase 4, single-center, open-label, pilot study | 1,500 mg on day 0 and days 8–10 | None | Clinical success and relapse at 6 wk | Not yet recruiting | Excludes left-sided IE, requires prove of negative blood cultures. |
| NTC03426761 | 50 | BJI, including PJI and septic arthritis | Phase 4, randomized, open-label, pilot study | 1,500 mg on day 0 and every 14 days (2–4 times) | SOC | Clinical cure at 6 wk | Recruiting | Confirmed Gram positive on culture |
| NTC04775953 | 200 | Complicated S. aureus bacteremia or right-sided native valve IE | Phase 2b, multicenter, randomized, open-label, assessor-blind, superiority study | 1,500 mg on days 1 and 8 | SOC | Clinical success (DOOR) | Recruiting | Patients must have cleared their baseline bacteremia |
| NTC05046860 | 43 | Acute or chronic PJI of knee or hip (1st episode) due to Staphylococcus spp. | Single group, open label | 1,500 mg on days 0, 15, and 36 | None | Clinical success at 48 wk | Not yet recruiting | Patients will also receive rifampin 600 mg daily, all patients undergo surgical debridement with implant retention (acute infections) or 1-stage revision (chronic infections) |
| NTC05117398 | 406 | Noncomplicated CR-BSI due to S. aureus | Phase 3, pragmatic, open-label, noninferiority, randomized multicenter trial | 1,500 mg once | SOC | Clinical cure and relapse at day 30 | Not yet recruiting | Catheter removal required before entering study |
a
BJI, bone and joint infection; BSI, bloodstream infection; CR, catheter-related; DOOR, desirability of outcome ranking; IE, infective endocarditis; PJI, prosthetic joint infection; SOC, standard of care. Information was obtained from www.clinicaltrials.gov. Only clinical studies with primary endpoints focusing on clinical outcomes were included.
b
The aim is to complete the last 2 weeks of therapy out of a total of 4 weeks for bacteremia and 6 weeks for infective endocarditis.