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

This study has been terminated.
(Study terminated due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00055198
First received: February 20, 2003
Last updated: June 12, 2017
Last verified: June 2017
  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
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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals LLC:

Estimated Enrollment: 75
Actual Study Start Date: December 19, 2002
Study Completion Date: January 26, 2004
Primary Completion Date: January 26, 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 )
Study First Received: February 20, 2003
Last Updated: June 12, 2017

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

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

ClinicalTrials.gov processed this record on August 22, 2017