Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections

Phase 4

Terminated

• Conditions: Staphylococcal Skin Infections
• Interventions: Drug: Daptomycin

• Registration Number: NCT00463801
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Primary Completion: 2007-11
• Results First Submitted: 2010-12-09
• Results First Submitted QC: 2010-12-09
• Results First Posted: 2010-12-23
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daptomycin	Daptomycin	350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous	At day 14
Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE	At day 14
Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10	At day 4 and 10	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 interim visits on day 4 (D4) and day 10 (D10) 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.
Efficacy Assessed by Time of Resolution of Infection	At day 14	Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature ≤37.5°C).
Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria	At day 4, 7, 10 and 14	To evaluate the microbiological 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 proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.
Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)	at day 14 and follow up day i.e. day 30

Trial Locations

Locations (1)

Novartis Italy; 🇮🇹 Saronno, Italy