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Levonadifloxacin vs Linezolid in ABSSSI
NCT03405064Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2017
- Primary completion
- Sep 2018
- Countries
- 1
- Sponsor
- Wockhardt
- Modality
- Orthosteric Ligands
- Drugs
- levonadifloxacin
- Conditions
- acute bacterial skin and skin structure infection (ABSSSI)
01
Overview
Phase 3, randomised, open-label trial of levonadifloxacin in acute bacterial skin and skin structure infection (ABSSSI) (2 arms), sponsored by Wockhardt. Primary endpoint: Overall Clinical Response at Test of Cure (TOC) visit. Started Aug 2017; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Levonadifloxacin
Levonadifloxacin IV (800 mg BID) or Oral (1000 mg BID)
Linezolid
Linezolid IV (600 mg BID) or Oral (600 mg BID)
03
Who it enrols
Adult patients (18-65 years) with ABSSSI (cellulitis, wound infection, or major cutaneous abscess) with a lesion size >= 75 cm2 and suspected/documented Gram-positive infection. Excludes patients with severe arterial impairment, osteomyelitis, gangrene, or those who received prior effective antibiotics.
04
Endpoints
Primary
Overall Clinical Response at Test of Cure (TOC) visit
Secondary
Safety of oral and IV levonadifloxacin
05
Results
Primary endpoints met
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