Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections

NCT00430937 | Terminated Phase 3 Results

• 1 other identifier: CCBC134A2402
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections

Conditions

Skin Diseases, Infectious; Soft Tissue Infections

Keywords

Complicated Skin and Soft Tissue Infections. Daptomycin, Vancomycin, Teicoplanin; Complicated skin and soft tissue infections

Outcome Measures

Primary Outcomes (1)

• Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the "Test of Cure" (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population.

  Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement). Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy.

  Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks

Secondary Outcomes (1)

• Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.

  Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks

Study Arms (2)

Daptomycin

EXPERIMENTAL

4 mg/kg intravenous (i.v.) once daily

Drug: Daptomycin

Pooled Comparator

ACTIVE COMPARATOR

Drug: Vancomycin; Drug: Teicoplanin

Interventions

Daptomycin DRUG

4 mg/kg intravenous once daily

Also known as: Cubicin

Daptomycin

Vancomycin DRUG

1 g intravenous twice daily

Also known as: Vancocin

Pooled Comparator

Teicoplanin DRUG

400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one.

Also known as: Targocid

Pooled Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a diagnosis of cSSTI
• Infection known or suspected (based on Gram's stain) to be due, at least partially, to Gram-positive bacteria.
• Hospitalised subjects with clinical evidence of at least one of the following:I infected ulcers , major abscess. deep or extensive cellulitis, post-surgical / post-traumatic wound infection
• Presence of at least two of the following: drainage and/or discharge from the infection site, redness, swelling and/or hardened skin, heat and/or localised warmth, pain and/or tenderness to touch, presence of pus.

You may not qualify if:

• cSSTIs of the following categories:
• Infected burns,
• Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely),
• Decubitus ulcers,
• Infected diabetic foot ulcers associated with osteomyelitis,
• Infected human or animal bites, superficial infections or abscesses in an anatomic site, such as the rectal area, where the risk of anaerobic or Gram-negative pathogen involvement is high (e.g. perirectal abscess),
• Necrotising fasciitis or gangrene,
• cSSTI 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 randomisation
• Subjects with documented bacteraemia at Baseline or those with shock or hypotension
• Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluations in this protocol
• Treatment with vancomycin or teicoplanin within the past 48 hours, unless administered for less than 24 hours.
• Subjects admitted to the hospital for conditions associated with rhabdomyolysis or those with an infection due to an organism known prior to study entry to be resistant to daptomycin, vancomycin or teicoplanin.
• Previously diagnosed disease of immune function. Human Immunodeficiency Virus (HIV) infected subjects without Acquired Immune Deficiency Syndrome (AIDS) may be enrolled.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Skin Diseases, Infectious; Soft Tissue Infections

Interventions

Daptomycin; Vancomycin; Teicoplanin

Condition Hierarchy (Ancestors)

Infections; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Glycopeptides; Glycoconjugates; Carbohydrates; Lipoglycopeptides

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis

  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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2007
• First Posted: February 2, 2007
• Study Start: April 1, 2006
• Primary Completion: March 1, 2008
• Last Updated: July 16, 2012
• Results First Posted: January 5, 2011

Record last verified: 2012-07