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

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ClinicalTrials.gov Identifier: NCT00055198
Recruitment Status : Terminated (Study terminated due to low enrollment)
First Posted : February 21, 2003
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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 : December 19, 2002
Primary Completion Date : January 26, 2004
Study Completion Date : January 26, 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00055198     History of Changes
Other Study ID Numbers: 3009-012
DAP-EAP-02-01 ( Other Identifier: Cubist )
First Posted: February 21, 2003    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Cubist Pharmaceuticals LLC:
Gram positive bacterial infections
expanded access program
resistant infections
Bacterial and fungal infections
bacterial infections

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Gram-Positive Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents