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Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections
This study has been completed.
First Received: February 1, 2007   Last Updated: July 13, 2009   History of Changes
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00430937
  Purpose

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


Condition Intervention Phase
Skin Diseases, Infectious
Soft Tissue Infections
Drug: Daptomycin
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Assessor-Blind Study to Evaluate Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections (cSSTI)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Clinical success assessed by comparing the subject's signs and symptoms (purulent drainage, warmth, fever, erythema, pain) between the first study visit and the assessment visit after treatment.

Secondary Outcome Measures:
  • Microbiological response for each Gram-positive pathogen isolated at study baseline visit assessed by a new culture at the Test of Cure visit.
  • Occurrence of a new infection defined by any of the following criteria occurring before the Follow-up assessment (Day +21 to +28):
  • Isolation of a new pathogen from the culture of a lesion in the presence of signs and symptoms of infection ("superinfection" if during treatment);
  • Isolation of any pathogen from a new site of infection with associated clinical signs and symptoms; or
  • Presence of clinical signs and symptoms indicative of a new infection.
  • Time to resolution of systemic and local signs and symptoms of cSSTI assessed by a SSTI signs and symptoms scoring system.
  • Normalization of fever for all subjects who are febrile at study Baseline assessed by at least 2 body temperature measurements not less than 12 hours apart
  • Duration of treatment with daptomycin (total cumulative dose received and the number of treatment days)

Estimated Enrollment: 280
Study Start Date: April 2006
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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, swellingand/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. HIV infected subjects without 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
  • Previous history of hearing loss. Other protocol defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430937

Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CCBC134A2402
Study First Received: February 1, 2007
Last Updated: July 13, 2009
ClinicalTrials.gov Identifier: NCT00430937     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices;   Spain: Spanish Agency of Medicines;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   France: French Health Products Safety Agency

Keywords provided by Novartis:
Complicated Skin and Soft Tissue Infections. Daptomycin, Vancomycin, Teicoplanin
Complicated skin and soft tissue infections

Additional relevant MeSH terms:
Daptomycin
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Skin Diseases, Infectious
Teicoplanin
Soft Tissue Infections
Skin Diseases
Therapeutic Uses
Vancomycin
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010