Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)

Recruitment status:
Not recruiting
Primary Sponsor:
Cubist Pharmaceuticals LLC
Recruitment countries:
United States
Health condition studied:
Infective Endocarditis
Link to the clinical trial website

About the trial

Drug: daptomycin
Drug: daptomycin and gentamicin
Key inclusion and exclusion criteria:

  • Inclusion Criteria:

    1. Written informed consent has been obtained;

    2. Male or female =18 years of age;

    3. IVDU (as confirmed by history of drug abuse within the past 3 months or recent needle
    track marks);

    4. Definite or possible IE according to the modified Duke Criteria (see Appendix A); [17

    5. Two blood cultures positive for S. aureus obtained within 96 hours prior to first
    dose of study medication acquired by fresh venipuncture using aseptic technique and
    analyzed at the local laboratory (see Appendix B).

    Exclusion Criteria:

    1. Intravascular foreign material in place at the time that the positive blood culture
    was drawn (e.g., intracardiac pacemaker wires, percutaneous or implanted venous
    catheters, vascular grafts), (exception: vascular stents that have been in place for
    >6 months or permanent pacemaker wires attached via epicardial leads are allowed);

    2. High likelihood of LIE as indicated by:

    1. Prior diagnosis of predisposing left-sided valvular pathology (e.g., rheumatic
    heart disease, bicuspid aortic valve); or

    2. Findings on screening examination of left-sided valvular pathology (e.g.,
    diastolic murmur of aortic insufficiency); or

    3. Findings on screening examination of major systemic emboli to visceral organs
    (e.g. cerebral or splenic infarct). Patients may be included if their only
    findings are consistent with microvascular phenomena due to immune complexes
    (e.g., splinter hemorrhages, conjunctival petechiae, Roth's spots, Osler's
    nodes, Janeway's lesions, microhematuria).

    Note: Any patient enrolled in the study that is subsequently found to have LIE may be
    continued in the trial if determined to be clinically improving by the Investigator.

    3. Prosthetic heart valve;

    4. Baseline Creatinine clearance of <30 mL/min (as calculated by the Cockcroft-Gault
    equation using actual body weight);

    5. Baseline CPK value 5 X upper limit of normal (ULN) in conjunction with symptoms of
    myalgia or baseline CPK value 10 X ULN without symptoms;

    6. Alanine aminotransferase (ALT) >5 X ULN;

    7. Aspartate aminotransferase (AST) >5 X ULN;

    8. Moribund clinical condition (i.e. high likelihood of death within 3 days after

    9. Shock or hypotension (supine systolic blood pressure <80 mm Hg) or oliguria (urine
    output <20 mL/h) unresponsive to fluids or pressors within 4 hours;

    10. Known pneumonia or osteomyelitis;

    11. Polymicrobial infection or bacteremia due to a pathogen other than S. aureus;

    12. Neutropenia (absolute neutrophil count < 0.5 X 103/µL) and/or lymphopenia (CD4
    lymphocytes <0.2X 103/µL);

    13. Anticipated to require non-study antibiotics that may be potentially effective
    against S. aureus;

    14. Prior gentamicin therapy > 1 day;

    15. Documented history of significant allergy or intolerance to any of the study

    16. Unlikely to comply with study procedures;

    17. Pregnant or nursing. All females with childbearing potential will have a pregnancy
    test performed at the local laboratory.

    18. Female of childbearing potential and not willing to practice barrier methods of birth
    control (e.g., condoms or diaphragms together with spermicidal foam or gel) during
    treatment and for at least 28 days after treatment with study medication
  • Age minimum:  18 Years
  • Age maximum:  N/A
  • Gender:  Both
Primary outcomes:
Summary of Clinically Significant Increases in Serum Creatinine by Visit
Secondary outcomes:
Summary of the Investigator's Assessment of Clinical Response at the TOC Visit
Target sample size:
Study type:
Study design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Name:   Paula Bokesch, M.D.
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Cubist Pharmaceuticals LLC

Technical details

Scientific title:
A Phase 4 Multicenter, Randomized, Double Blind Study to Describe the Efficacy and Safety of Cubicin® (Daptomycin for Injection) With and Without Initial Gentamicin Combination Therapy in the Treatment of S. Aureus Infective Endocarditis
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
Secondary ID:
Date of registration:
Date of first enrollment:
March 2008
Last refreshed:
18 January 2016


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