Cubicin(R) for Complicated Post-surgical Wound Infections

NCT00651131 | Terminated Phase 4

• 2 other identifiers: 3009-011DAP-4PSW-03-03
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections

Conditions

Wound Infections

Keywords

post-surgical; wound infection; superficial; deep; surgical

Outcome Measures

Primary Outcomes (1)

• Investigator's assessment of clinical response based on improvement of signs and symptoms

  End of Therapy

Secondary Outcomes (3)

• Incidence of adverse events

  first dose to end of therapy

• eradication of pathogens isolated at admission

  End of Therapy

• overall therapeutic outcome based on agreement between clinical efficacy and microbiological response

  End of Therapy

Interventions

daptomycin DRUG

daptomycin i.v. 4 mg/kg q24h for 7-14 days

Also known as: Cubicin, daptomycin for injection, Cubicin (daptomycin for injection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Read and signed informed consent form
• female of childbearing potential, negative pregnancy test result
• Confirmed diagnosis of post-surgical wound infections known or suspected (based on Gram stain) to be due to Gram-positive organisms obtained within 3 calendar days prior to first dose of study medication
• Onset of surgical wound infection within 30 days after surgery
• At least three clinical signs and symptoms of skin infection

You may not qualify if:

• previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug
• Uncomplicated surgical infections (eg, stitch abscesses)
• osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
• Any type of space infection
• Conditions requiring surgical removal of wound infection
• necrotizing fasciitis, synergistic gangrene, Clostridial myonecrosis (gas gangrene), or Fournier's gangrene;
• Foreign material involved in the post-surgical wound infection
• Known to be allergic or intolerant to study medication
• Creatinine Clearance (CLCR) \<30 mL/min
• history of neurological disease (eg, Guillain-Barré, multiple sclerosis)

Sponsors & Collaborators

• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

MeSH Terms

Conditions

Wound Infection

Interventions

Daptomycin; Injections

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: June 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: August 30, 2017

Record last verified: 2017-08