Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

September 13, 2010 updated by: Cubist Pharmaceuticals LLC

Phase 2 Multicenter Randomized Semi-Single Blind Study to Compare Efficacy and Safety of High-dose Short Duration Daptomycin With Conventional Therapy in Complicated Skin and Skin Structure Infections Due to Gram-positive Bacteria

multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.

The main criteria for evaluation will be:

  • Efficacy
  • Safety
  • Microbiologic eradication

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Idaho Falls Infectious Diseases, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Informed consent obtained
  2. Male or female ≥18 years of age
  3. If female of childbearing potential, willing to practice reliable birth control measures and documented negative pregnancy test
  4. Skin and skin structure infections of a complicated nature that require intravenous antibiotic treatment
  5. Gram-positive infecting pathogen
  6. Physician determination that vancomycin would be the initial treatment of choice

  7. At least three clinical signs and symptoms associated with the cSSSI:

    • Pain;
    • Tenderness to palpation;
    • Elevated Temperature;
    • Elevated White blood count;
    • Swelling and/or induration;
    • Erythema (>1 cm beyond edge of wound or abscess);
    • Pus formation;
  8. Creatinine clearance of ≥50 mL/min.

Exclusion Criteria:

  1. MSSA
  2. Known or suspected bacteremia, osteomyelitis, or endocarditis
  3. Primary study infection of an uncomplicated nature such as furuncles, simple abscesses, cellulitis not requiring i.v., perirectal abscess, hidradenitis suppurativa, third degree burn infections or other minor infections;
  4. Conditions where required surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation);
  5. Necrotizing infections or concomitant gangrene;
  6. Myositis with or without skin and skin structure infections;
  7. Hemodialysis or peritoneal dialysis;
  8. BMI ≥40 kg/m2;
  9. Previous antibiotics exceeding 24 hours within the 48 hours prior to the first dose of study drug
  10. Patients admitted for rhabdomyolysis including drug overdose
  11. Neutropenic patients with absolute neutrophil count ≤500 cells/mm3
  12. Known HIV-infected patients with CD4 count ≤200 cells/ mm3;
  13. Baseline CPK values ≥2 X ULN (upper limit of normal);
  14. Has received an investigational drug within 30 days of study entry;
  15. Known to be allergic or intolerant to study medications;
  16. unlikely to comply with study procedures
  17. Is expected to receive HMG CoA Reductase Inhibitors from enrollment through End of Treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical Response Rate at TOC

Secondary Outcome Measures

Outcome Measure
difference between clinical response rates at EOT
microbiological eradication rates

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cubist Pharmaceuticals LLC

Investigators

  • Principal Investigator: Richard Nathan, D.O., Idaho Falls Infectious Diseases, PLLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 23, 2007

First Submitted That Met QC Criteria

January 24, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 13, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAP-HDSD-06-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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