WHO ICTRP trial

Study to Compare the Efficacy and Safety of Single Dose Dalbavancin to a Two…

EUCTR2014-000419-15-LV · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2014-000419-15-LV
Public title Study to Compare the Efficacy and Safety of Single Dose Dalbavancin to a Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Scientific title A Phase 3b, Double-Blind, Multicenter, Randomized Study to Compare the Efficacy and Safety of Single Dose Dalbavancin to a Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Primary sponsor Durata Therapeutics International B.V.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Countries Serbia;United States;Hungary;Estonia;Ukraine;Romania;Croatia;Russian Federation;Georgia;Bulgaria;South Africa;Latvia
Conditions Acute Bacterial Skin and Skin Structure Infections MedDRA version: 17.1 Level: PT Classification code 10052891 Term: Skin bacterial infection System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Skin…
Interventions Trade Name: Dalvance Product Name: Dalbavancin Product Code: DUR001 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: DALBAVANCIN CAS Number: 171500-79-1 Current Sponsor code: DUR001 Concentration…
Registration date Apr 7, 2014
Target size 698
Secondary IDs DUR001-303;60,613
Registry page clinicaltrialsregister.eu

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