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

Sponsor

Cubist Pharmaceuticals LLC (Industry)

Overall Status

Terminated

CT.gov ID

NCT00055198

Collaborator

(none)

Enrollment

13.2

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gram-Positive Bacterial Infections	Drug: daptomycin	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 19, 2002

Actual Primary Completion Date :

Jan 26, 2004

Actual Study Completion Date :

Jan 26, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.