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

Phase 3

Terminated

• Conditions: Gram-Positive Bacterial Infections

• Registration Number: NCT00055198
• Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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

Not available

Study Timeline

• Study Start: 2002-12-19
• Study First Submitted: 2003-02-20
• Study First Submitted QC: 2003-02-20
• Study First Posted: 2003-02-21
• Primary Completion: 2004-01-26
• Study Completion: 2004-01-26
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-12
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified