A Multicentre, Open Label, Uncontrolled Clinical Trial to Evaluate Efficacy and Safety of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections (cSSTI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)

NCT00463801 Phase 4 TERMINATED Results posted

This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults

Details

Lead sponsor	Novartis
Phase	Phase 4
Status	TERMINATED
Enrolment	52
Start date	2007-01

Conditions

• Staphylococcal Skin Infections

Interventions

• Daptomycin

Primary outcomes

• Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start — at Day 7 and 14
  Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.

Countries

Italy