Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00463801

Purpose

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

Condition	Intervention	Phase
Staphylococcal Skin Infections	Drug: Daptomycin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Skin Infections

Drug Information available for: Daptomycin

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start [ Time Frame: at Day 7 and 14 ] [ Designated as safety issue: No ]
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 [ Time Frame: At day 4, 7, 10 and 14 ] [ Designated as safety issue: No ]
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 [ Time Frame: At day 4 and 10 ] [ Designated as safety issue: No ]
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 [ Time Frame: At day 14 ] [ Designated as safety issue: No ]
Efficacy Assessed by Time of Resolution of Infection [ Time Frame: At day 14 ] [ Designated as safety issue: No ]
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 [ Time Frame: At day 14 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	January 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Daptomycin 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.	Drug: Daptomycin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463801

Locations

Italy
Novartis Italy
Novartis Italy, Italy
Novartis Italy
Saronno, Italy

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00463801 History of Changes
Other Study ID Numbers:	CCBC134AIT01
Study First Received:	April 19, 2007
Results First Received:	December 9, 2010
Last Updated:	March 22, 2011
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Novartis:

Complicated Skin and Skin-Structure Infections, Daptomycin, MRSA, Diabetic Foot, Abscess, Cellulitis
Complicated skin and skin-structure infections

Additional relevant MeSH terms:

Skin Diseases, Infectious
Staphylococcal Skin Infections
Infection
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

Skin Diseases, Bacterial
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012