Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

Novartis

Status and phase: Completed; Phase 3

Conditions: Infections

Treatments: Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs); Drug: Daptomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01184872

CCBC134A2404

2009-014391-22 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.

Enrollment: 120 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients 65 years or older with infection of sufficient severity to require in-patient hospitalization, with parenteral antimicrobial therapy for at least 96 hours.

Patients who have a diagnosis of Gram-positive complicated Skin and Soft Tissue Infections (cSSTIs) with or without bacteremia:

• Wound infections,
• Major abscesses with or without recognized preceding trauma, that require antibiotic therapy in addition to surgical incision and drainage,
• Severe carbunculosis,
• Infected ulcers (except patients with multiple infected ulcers) associated with: diabetes, vascular insufficiency, pressure (i.e., decubitus ulcers).

Exclusion criteria

Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (e.g., amputation).

Minor or superficial skin infections (e.g., furuncles, simple abscesses, acne, impetigo).

Cellulitis, including erysipelas, not associated with complicating factors. However, patients with cellulitis associated with more serious infection (e.g., surgical wound, diabetic ulcer, deep tissue) can be enrolled (proportion of these patients will be limited to 30%).

Infections for which outcome is difficult to assess:

• Perirectal abscess,
• Hidradenitis suppurativa,
• Gangrene,
• Infected human or animal bites,
• Multiple infected ulcers at distant sites,
• Infected burns (only third degree burn wound or wound area of more than 10 cm diameter),
• Conditions requiring emergency surgery including necrotizing fasciitis.

Medical conditions:

• History of significant allergy or intolerance to Vancomycin or Daptomycin. Hypersensitivity to SSPs penicillins is not an exclusion criterion,
• Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluation in this protocol,
• Infections associated with a permanent prosthetic device that will not be removed within 24 hours after enrolment,
• Known or suspected HIV infection with a CD4+ T-cell count < 500/μL (HIV testing is not required),
• Severe hepatic disease (Child-Pugh Class C) or ALT and/or AST > 5 times ULN and/ or total bilirubin > 2 times ULN at screening,
• Calculated creatinine clearance by the Cockcroft-Gault equation using actual body weight < 30 mL/min or any type of dialysis,
• Treatment with any investigational agent or device within 30 days of study drug administration.

Exclusion criteria related to medications:

• Previous systemic antibacterial therapy for the treatment of Gram-positive complicated skin and soft tissue infections for more than 24 hours within 48 hours prior to the day of first infusion of study drug unless:
• The previous antibacterial therapy was administered for 3 or more calendar days with either worsening or no improvement in the clinical signs and symptoms of cSSTIs, and was not Vancomycin or SSPs.

Other protocol-defined inclusion/exclusion criteria applied.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Daptomycin

Experimental group

Description:

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days. Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Treatment:

Drug: Daptomycin

Vancomycin or Semi-Synthetic Penicillins (SSPs)

Active Comparator group

Description:

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days. Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Treatment:

Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs)