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

NCT ID: NCT00430937

Last Updated: 2012-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Daptomycin

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

Group Type: EXPERIMENTAL

Daptomycin

Intervention Type: DRUG

4 mg/kg intravenous once daily

Pooled Comparator

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

1 g intravenous twice daily

Teicoplanin

Intervention Type: DRUG

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

Interventions

Daptomycin

4 mg/kg intravenous once daily

Intervention Type: DRUG

Vancomycin

1 g intravenous twice daily

Intervention Type: DRUG

Teicoplanin

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

Intervention Type: DRUG

Other Intervention Names

Cubicin; Vancocin; Targocid

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Subjects receiving oral steroids or receiving immunosuppressant drugs after organ transplant.
• Absence of purulent material for initial culture and Gram's stain. Subjects with cellulitis may be enrolled in the absence of purulent material, provided that infection with a Gram-positive organism is suspected.
• Subjects who have received more than 48 hours of any systemic antibiotic or topical antibiotic at the infection site with activity against Gram-positive pathogens, unless there is clinical evidence of treatment failure OR documented resistance in the identified Gram-positive pathogen to the previous antibiotic therapy.
• cSSTI suspected or documented as being due exclusively to Gram-negative or anaerobic organisms based on epidemiology or on direct examination of a Gram-stained specimen.
• Subjects diagnosed with pneumonia or those with severe renal impairment or hepatic disease

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

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis

Countries

Switzerland

Other Identifiers

CCBC134A2402

Identifier Type: -

Identifier Source: org_study_id