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

This study has been completed.

First Received: February 20, 2003 Last Updated: January 30, 2007 History of Changes

Sponsor:	Cubist Pharmaceuticals
Information provided by:	Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00055198

Purpose

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	Intervention	Phase
Gram-Positive Bacterial Infections	Drug: daptomycin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bacterial Infections

Drug Information available for: Daptomycin

U.S. FDA Resources

Further study details as provided by Cubist Pharmaceuticals:

Estimated Enrollment:	75
Study Start Date:	January 2003
Estimated Study Completion Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	DAP-EAP-02-01
Study First Received:	February 20, 2003
Last Updated:	January 30, 2007
ClinicalTrials.gov Identifier:	NCT00055198 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:

Gram positive bacterial infections
expanded access program
resistant infections

bacteremia
Bacterial and fungal infections
bacterial infections

Additional relevant MeSH terms:

Daptomycin
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Gram-Positive Bacterial Infections
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009