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

NCT ID: NCT00463801

Last Updated: 2011-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31

Brief Summary

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

Conditions

Staphylococcal Skin Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Daptomycin

Intervention Type: DRUG

Interventions

Daptomycin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with a diagnosis of complicated skin and skin-structure infections (cSSTI) defined as infection normally requiring surgical/local debridement of sufficient severity to warrant hospitalization and intravenous antimicrobial treatment
• Infection to be due to Gram-positive bacteria
• Hospitalized subjects
• Written informed consent
• Female patients of childbearing potential must have a negative pregnancy test urine or serum at baseline and must use effective contraception throughout the study period.

Exclusion Criteria

• Complicated skin and skin-structure infections of the following categories:
• Infected burns
• Severely impaired arterial blood supply
• Decubitus ulcers
• Infected diabetic foot ulcers associated with osteomyelitis
• Infected human or animal bites
• Perirectal abscess
• Necrotising fasciitis or gangrene
• Infections expected to require more than 14 days of intravenous antimicrobial therapy
• Skin and/or skin structure infection that can be treated by surgery alone
• Infections associated with a permanent prosthetic device that will not be removed within 2 days of study enrollment
• Uncomplicated skin or soft tissue infection
• Documented bacteremia at baseline
• Concomitant infection nearby the site of infection at baseline, potentially interfering with the evaluations
• Hospitalization for conditions related to rhabdomyolysis
• Human immunodeficiency virus (HIV) with cluster of differentiation (CD) < 200 or < 14%
• Immune function alterations
• Lack of sufficient purulent material for culture and Gram test
• Systemic or local antibiotic administration with known anti-Gram positive activity in the preceding 48 hours
• Complicated skin and soft tissue infections (cSSTI) known or believed to be related to fungal, parasitic or viral infection
• Pneumonia
• Local or systemic known or suspected allergy to daptomycin
• Creatinine clearance < 30 mL/min
• Severe liver damage (Child-Pugh class C) or Alanine transaminase (ALT) and/or Aspartate aminotransferase (AST) > 3 x Upper limit of normal (ULN) and/or bilirubin > 1.5 x ULN
• Use of any experimental drugs in the preceding 30 days
• Severe medical conditions that in the investigator's opinion could counter indicate participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

Novartis Italy

Novartis Italy, , Italy

Novartis Italy

Saronno, , Italy

Countries

Italy

Other Identifiers

CCBC134AIT01

Identifier Type: -

Identifier Source: org_study_id