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

Tracking Information
First Received Date ^ICMJE	February 20, 2003
Last Updated Date	January 30, 2007
Start Date ^ICMJE	January 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00055198 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria
Official Title ^ICMJE	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
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 Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Condition ^ICMJE	Gram-Positive Bacterial Infections
Intervention ^ICMJE	Drug: daptomycin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	75
Completion Date	January 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00055198
Responsible Party
Study ID Numbers ^ICMJE	DAP-EAP-02-01
Study Sponsor ^ICMJE	Cubist Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cubist Pharmaceuticals
Verification Date	December 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP