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

NCT01184872 | Completed Phase 3 Results

• 2 other identifiers: CCBC134A24042009-014391-22
• Study Type: interventional
• Target: 120
• Locations: 5 countries
• Sites: 17

Brief Summary

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.

Conditions

Infections

Keywords

Skin infection; Daptomycin; Elderly; Gram positive; Complicated skin and soft tissue infections

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit

  Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.

  Baseline and 7 to 14 days after end of therapy

Secondary Outcomes (4)

• Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit

  Baseline and 7 to 14 days after end of therapy

• Duration of Treatment (Intravenous)

  Up to 28 days

• Duration of Treatment (Intravenous and Oral)

  Up to 28 days

• Number of Patients With Adverse Events, Serious Adverse Events and Death

  Continuously from baseline up to 28 days after end of antibiotic treatment.

Study Arms (2)

Daptomycin

EXPERIMENTAL

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.

Drug: Daptomycin

Vancomycin or Semi-Synthetic Penicillins (SSPs)

ACTIVE COMPARATOR

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.

Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs)

Interventions

Daptomycin DRUG

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.

Daptomycin

Vancomycin or Semi-Synthetic Penicillins (SSPs) DRUG

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.

Also known as: Oxacillin,, Cloxacillin,, Flucloxacillin,

Vancomycin or Semi-Synthetic Penicillins (SSPs)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• 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),

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Novartis Investigative Site

Graz, Austria

Location

Novartis Investigative Site

Vienna, Austria

Location

Novartis Investigative Site

Bochum, Germany

Location

Novartis Investigative Site

Essen, Germany

Location

Novartis Investigative Site

Homburg, Germany

Location

Novartis Investigative Site

Magdeburg, Germany

Location

Novartis Investigative Site

Mannheim, Germany

Location

Novartis Investigative Site

Münster, Germany

Location

Novartis Investigative Site

Tübingen, Germany

Location

Novartis Investigative Site

Pisa, Italy

Location

Novartis Investigative Site (1)

Moscow, Russia

Location

Novartis Investigative Site

Novosibirsk, Russia

Location

Novartis Investigative Site (2)

Saint Petersburg, Russia

Location

Novartis Investigative Site

Yaroslavi, Russia

Location

Novartis Investigative Site (1)

Madrid, Spain

Location

Novartis Investigative Site

Santander, Spain

Location

Novartis Investigative Site

Seville, Spain

Location

Related Publications (1)

• Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI; Daptomycin 98-01 and 99-01 Investigators. The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. Clin Infect Dis. 2004 Jun 15;38(12):1673-81. doi: 10.1086/420818. Epub 2004 May 20.

  PMID: 15227611 BACKGROUND

MeSH Terms

Conditions

Infections; Cellulitis; Soft Tissue Infections

Interventions

Daptomycin; Vancomycin; Oxacillin; Cloxacillin; Floxacillin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Glycopeptides; Glycoconjugates; Carbohydrates; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceutical

862 778 8300

Study Officials

• Novartis Pharmceuticals

  Novartis Pharmceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: August 19, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 13, 2012
• Results First Posted: April 18, 2012

Record last verified: 2012-07

Locations

DE (7); ES (3); RU (4); AU (2); IT (1)