Back to resultsSafety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
Primary Purpose
Staphylococcal Skin Infections
Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Daptomycin
Sponsored by
About this trial
This is an interventional treatment trial for Staphylococcal Skin Infections focused on measuring Complicated Skin and Skin-Structure Infections, Daptomycin, MRSA, Diabetic Foot, Abscess, Cellulitis, Complicated skin and skin-structure infections
Eligibility Criteria
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 hospitalization and intravenous antimicrobial treatment
- Infection to be due to Gram-positive bacteria
- Hospitalized 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 rhabdomyolysis
- Human immunodeficiency virus (HIV) with cluster of differentiation (CD) < 200 or < 14%
- Immune function alterations
- Lack of sufficient purulent material for culture and Gram test
- Systemic or local antibiotic administration with known anti-Gram positive activity in the preceding 48 hours
- Complicated skin and soft tissue infections (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 < 30 mL/min
- Severe liver damage (Child-Pugh class C) or Alanine transaminase (ALT) and/or Aspartate aminotransferase (AST) > 3 x Upper limit of normal (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
Sites / Locations
- Novartis Italy
- Novartis Italy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Daptomycin
Arm Description
350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
Outcomes
Primary Outcome Measures
Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start
Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.
Secondary Outcome Measures
Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria
To evaluate the microbiological efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.
Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10
To evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the interim visits on day 4 (D4) and day 10 (D10) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.
Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous
Efficacy Assessed by Time of Resolution of Infection
Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature ≤37.5°C).
Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE
Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00463801
Brief Title
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Because of inadequate accrual.
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Skin Infections
Keywords
Complicated Skin and Skin-Structure Infections, Daptomycin, MRSA, Diabetic Foot, Abscess, Cellulitis, Complicated skin and skin-structure infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daptomycin
Arm Type
Experimental
Arm Description
350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Primary Outcome Measure Information:
Title
Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start
Description
Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.
Time Frame
at Day 7 and 14
Secondary Outcome Measure Information:
Title
Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria
Description
To evaluate the microbiological efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.
Time Frame
At day 4, 7, 10 and 14
Title
Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10
Description
To evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the interim visits on day 4 (D4) and day 10 (D10) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.
Time Frame
At day 4 and 10
Title
Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous
Time Frame
At day 14
Title
Efficacy Assessed by Time of Resolution of Infection
Description
Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature ≤37.5°C).
Time Frame
At day 14
Title
Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE
Time Frame
At day 14
Title
Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)
Time Frame
at day 14 and follow up day i.e. day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 hospitalization and intravenous antimicrobial treatment
Infection to be due to Gram-positive bacteria
Hospitalized 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 rhabdomyolysis
Human immunodeficiency virus (HIV) with cluster of differentiation (CD) < 200 or < 14%
Immune function alterations
Lack of sufficient purulent material for culture and Gram test
Systemic or local antibiotic administration with known anti-Gram positive activity in the preceding 48 hours
Complicated skin and soft tissue infections (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 < 30 mL/min
Severe liver damage (Child-Pugh class C) or Alanine transaminase (ALT) and/or Aspartate aminotransferase (AST) > 3 x Upper limit of normal (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Italy
City
Novartis Italy
Country
Italy
Facility Name
Novartis Italy
City
Saronno
Country
Italy
12. IPD Sharing Statement
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Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
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