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Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections
This study is currently recruiting participants.
Study NCT00463801   Information provided by Novartis
First Received: April 19, 2007   Last Updated: April 2, 2009   History of Changes

April 19, 2007
April 2, 2009
 
 
  • Efficacy assessed by swelling, redness, presence of pus, hardening of the skin, necrotic tissue, purulent drainage, tenderness, and ulceration at baseline, day 7 and day 14
  • Efficacy assessed as success (Test of Cure) after 4,7, 10 and 14 days of treatment with daptomycin on infecting Gram positive bacteria
  • Efficacy assessed as percentage of patients with clinical success (TOC) at day 4 and 10
  • Efficacy assessed by duration of treatment with daptomycin
  • Efficacy assessed by time of resolution of infection
  • Safety assessed by hematological and biochemical tests, urinalysis, and recording and follow-up of emerging AE and SAE.
Same as current
Complete list of historical versions of study NCT00463801 on ClinicalTrials.gov Archive Site
Complicated skin and skin-structure infections
Same as current
 
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections
A Multicentre, Open Label, Uncontrolled Clinical Trial to Evaluate Efficacy and Safety of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections (cSSTI) Caused by Methicillin-Resistant Staphylococcus Aureus (MRSA)

This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Staphylococcal Skin Infections
Drug: Daptomycin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
104
 
 

Inclusion criteria:

  • Subjects with a diagnosis of complicated skin and skin-structure infections cSSTI) defined as infection normally requiring surgical/local debridement of sufficient severity to warrant hospitalisation and intra venous antimicrobial treatment
  • Infection to be due to Gram-positive bacteria
  • Hospitalised subjects
  • Written informed consent
  • Female patients of childbearing potential must have a negative pregnancy test urine or serum) at baseline and must use effective contraception throughout the study period.

Exclusion criteria:

  • Complicated skin and skin-structure infections of the following categories:
  • Infected burns
  • Severely impaired arterial blood supply
  • Decubitus ulcers
  • Infected diabetic foot ulcers associated with osteomyelitis
  • Infected human or animal bites
  • Perirectal abscess
  • Necrotising fasciitis or gangrene
  • Infections 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 enrollment
  • Uncomplicated skin or soft tissue infection
  • Documented bacteremia at baseline
  • Concomitant infection nearby the site of infection at baseline, potentially interfering with the evaluations
  • Hospitalization for conditions related to rabdomyolysis
  • HIV with CD < 200 or < 14%
  • Immune function alterations
  • Lack of sufficient purulent material for colture and Gram test
  • Systemic or local antibiotic administration with known anti-Gram positive activity in the preceding 48 hours
  • cSSTI known or believed to be related to fungal, parasitic or viral infection
  • Pneumonia
  • Local or systemic known or suspected allergy to daptomycin
  • Creatinine clearance < 30mL/min
  • Severe liver damage (Child-Pugh class C) or ALT and/or AST > 3 x ULN and/or bilirubin > 1.5 x ULN
  • Use of any experimental drugs in the preceding 30 days
  • Severe medical conditions that in the investigator's opinion could counter indicate participation in the study
Both
18 Years and older
 
Contact: novartis 41613241111
Italy
 
NCT00463801
External Affairs, Novartis Pharmaceticals
CCBC134AIT01
Novartis
 
Study Director: Novartis Novartis
Novartis
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP