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

ID: NCT00055198
Status: Terminated
Phase: Phase 3
Start Date: December 19, 2002
First Submitted: February 20, 2003
Last Updated: June 12, 2017
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: N/A
Conditions: Gram-Positive Bacterial Infections
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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.

Detailed Description

Condition or disease Intervention/treatment Phase

Gram-Positive Bacterial Infections

Drug: daptomycin
Other Names
Phase 3

Tracking Information

First Submitted DateFebruary 20, 2003
Last Update Posted DateJune 12, 2017
Actual Start DateDecember 19, 2002
Actual Completion DateJanuary 26, 2004
Actual Primary Completion DateJanuary 26, 2004
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleDaptomycin for the Treatment of Infections Due to Gram-Positive Bacteria
Official TitleA 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
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
75
Allocation
Non-Randomized
Interventional Model
Not Available
Masking
None
Primary Purpose
Treatment
Conditions
Gram-Positive Bacterial Infections
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: daptomycin

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Terminated
Enrollment75
Completion DateJanuary 26, 2004
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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT00055198
Other Study ID Numbers
3009-012
DAP-EAP-02-01
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Not Available