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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

Drug Information available for: Daptomycin

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Complicated skin and skin-structure infections

Estimated Enrollment:

104

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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 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

Contacts and Locations

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

Contacts

Contact: novartis

41613241111

Locations

Italy
Novartis Italy	Recruiting
Novartis Italy, Italy
Contact: Novartis Basel 41 61 324 1111
Novartis Italy	Recruiting
Saronno, Italy
Contact: Renato Turrini 39 02 96543280 renato.turrini@pharma.novartis.com

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceticals ( External Affairs )
Study ID Numbers:	CCBC134AIT01
Study First Received:	April 19, 2007
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00463801 History of Changes
Health Authority:	Italy: Agenzia Italiana del Farmaco (AIFA)

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:

Bacterial Infections
Communicable Diseases
Anti-Infective Agents
Skin Diseases
Staphylococcal Skin Infections
Infection
Pharmacologic Actions

Daptomycin
Staphylococcal Infections
Anti-Bacterial Agents
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Skin Diseases, Bacterial
Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2009