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

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00055198
First received: February 20, 2003
Last updated: January 30, 2007
Last verified: December 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00055198     History of Changes
Other Study ID Numbers: DAP-EAP-02-01
Study First Received: February 20, 2003
Last Updated: January 30, 2007
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:
Bacterial Infections
Communicable Diseases
Gram-Positive Bacterial Infections
Infection
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014