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

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00426933
First received: January 23, 2007
Last updated: September 13, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Soft Tissue Infections
Drug: Daptomycin
Drug: Vancomycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Clinical Response Rate at TOC

Secondary Outcome Measures:
  • difference between clinical response rates at EOT
  • microbiological eradication rates

Enrollment: 100
Study Start Date: January 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426933

Locations
United States, Idaho
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, United States, 83404
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Principal Investigator: Richard Nathan, D.O. Idaho Falls Infectious Diseases, PLLC
  More Information

No publications provided by Cubist Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A. Wheeler, Cubist Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00426933     History of Changes
Other Study ID Numbers: DAP-HDSD-06-01
Study First Received: January 23, 2007
Last Updated: September 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
cSSSI
MRSA

Additional relevant MeSH terms:
Soft Tissue Infections
Infection
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014