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Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria

Primary Purpose

Gram-Positive Bacterial Infections

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
daptomycin
Sponsored by
Cubist Pharmaceuticals LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-Positive Bacterial Infections focused on measuring Gram positive bacterial infections, expanded access program, resistant infections, bacteremia, Bacterial and fungal infections, bacterial infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Infection caused by Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, or Enterococcus faecium that requires inpatient hospitalization and treatment with injectable antibiotics** Site of infection: complicated skin and skin structure infection; urinary tract infection; intra-abdominal infection; infective endocarditis; or bloodstream infection (including catheter-related). Pathogen resistant to, or patient intolerant of: beta-lactams, vancomycin, quinupristin/dalfopristin, or linezolid. Unable to receive any other standard commercially available antibacterial therapy for the infection. Main Exclusion Criteria: Creatinine clearance less than 40 mL/min** Hemodialysis or peritoneal dialysis Admitted to the hospital for drug overdose or other conditions associated with rhabdomyolysis, or is expected to require repeated intramuscular injections Creatine phosphokinase (CPK) level greater than 2.5 times above the upper limit of normal (ULN) at screening; if the elevation in CPK can be attributed to an obvious cause (eg, surgery)** Central nervous system infection Pulmonary infection. (**) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 20, 2003
    Last Updated
    June 12, 2017
    Sponsor
    Cubist Pharmaceuticals LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00055198
    Brief Title
    Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria
    Official Title
    A Compassionate Use Protocol for Intravenous Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria That Cannot be Adequately Treated With Currently Available Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Study terminated due to low enrollment
    Study Start Date
    December 19, 2002 (Actual)
    Primary Completion Date
    January 26, 2004 (Actual)
    Study Completion Date
    January 26, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cubist Pharmaceuticals LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to provide daptomycin, an antibiotic, to patients who are failing conventional therapy, or who cannot take approved antibiotics for one reason or another.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gram-Positive Bacterial Infections
    Keywords
    Gram positive bacterial infections, expanded access program, resistant infections, bacteremia, Bacterial and fungal infections, bacterial infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    75 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    daptomycin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Main Inclusion Criteria: Infection caused by Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, or Enterococcus faecium that requires inpatient hospitalization and treatment with injectable antibiotics** Site of infection: complicated skin and skin structure infection; urinary tract infection; intra-abdominal infection; infective endocarditis; or bloodstream infection (including catheter-related). Pathogen resistant to, or patient intolerant of: beta-lactams, vancomycin, quinupristin/dalfopristin, or linezolid. Unable to receive any other standard commercially available antibacterial therapy for the infection. Main Exclusion Criteria: Creatinine clearance less than 40 mL/min** Hemodialysis or peritoneal dialysis Admitted to the hospital for drug overdose or other conditions associated with rhabdomyolysis, or is expected to require repeated intramuscular injections Creatine phosphokinase (CPK) level greater than 2.5 times above the upper limit of normal (ULN) at screening; if the elevation in CPK can be attributed to an obvious cause (eg, surgery)** Central nervous system infection Pulmonary infection. (**) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.

    12. IPD Sharing Statement

    Learn more about this trial

    Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria

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