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

Novartis

Status and phase: Terminated; Phase 4

Conditions: Staphylococcal Skin Infections

Treatments: Drug: Daptomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00463801

CCBC134AIT01

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Daptomycin

Experimental group

Description:

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.

Treatment:

Drug: Daptomycin