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

NCT00463801 | Terminated Phase 4 Results

• 1 other identifier: CCBC134AIT01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Staphylococcal Skin Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  at Day 7 and 14

Secondary Outcomes (6)

• Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria

  At day 4, 7, 10 and 14

• Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10

  At day 4 and 10

• Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous

  At day 14

• Efficacy Assessed by Time of Resolution of Infection

  At day 14

• Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE

  At day 14

Study Arms (1)

Daptomycin

EXPERIMENTAL

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

Interventions

Daptomycin DRUG

Daptomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Novartis Italy

Novartis Italy, Italy

Location

Novartis Italy

Saronno, Italy

Location

MeSH Terms

Conditions

Staphylococcal Skin Infections; Diabetic Foot; Abscess; Cellulitis

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Inadequate accrual caused the premature study termination and the insufficient sample size, therefore none of the planned study analyses were performed; nor were any tabulations with descriptive statistics were provided.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 20, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2007
• Last Updated: March 24, 2011
• Results First Posted: December 23, 2010

Record last verified: 2011-03

Locations

IT (2)