Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting

NCT01175707 | Terminated Phase 4 Results

• 2 other identifiers: 3009-009DAP-4HOME-09-05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive vancomycin in a home-infusion setting.

Conditions

Complicated Skin or Skin Structure Infection

Outcome Measures

Primary Outcomes (8)

• Time Spent (Minutes) for Home Infusion Therapy

  Each participant is counted once per category. Avg=average; Admin=administer.

  Day 1 up to Day 14

• Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy

  The mean duration in home-infusion antibiotic therapy per participant is presented.

  Day 1 up to Day 14

• Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy

  Each participant is counted once per category.

  Day 1 up to Day 14

• Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy

  Day 1 up to Day 14

• Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy

  Day 1 up to Day 14

• Reasons for Nurse Visits During Home Infusion Therapy

  The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.

  Day 1 up to Day 14

• Reasons for Pharmacist Consultations During Home Infusion Therapy

  The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.

  Day 1 up to Day 14

• Percentage of Treatment Goals Met at End of Therapy

  Treatment goals included: 1. Elimination of infection/achieved desired response. 2. Laboratory values were within normal limits or improved indicating progress toward therapy goal. 3. Pain was controlled. 4. Participant did not have catheter site complications (eg,infection, loss of patency). 5. Participant had no knowledge deficits related to administration, equipment use, side effects and waste disposal. 6. Participant had no side effects, adverse drug reactions and/or drug or food interactions. 7. Signs and symptoms of infection did improve or resolve. 8. Participant was compliant with IV therapy 9. Successfully completed therapy without interruptions, unexpected hospitalizations. 10. Participant continued on an oral antibiotic. 11. Participant continued on an IV antibiotic. Each participant's percentage was derived from number of treatment goals achieved out of a maximum of 11 goals. Reported percentage below is the average of all participants' percentage of goals met by arm.

  Day 1 up to Day 14

Secondary Outcomes (7)

• Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy

  Day 1 up to Day 14

• Mean Number of Interventions Per Participant During Home Infusion Therapy

  Day 1 up to Day 14

• Number of Intervention Types During Home Infusion Therapy

  Day 1 up to Day 14

• Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy

  Day 1 up to Day 14

• Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy

  Day 1 up to Day 14

Study Arms (2)

Daptomycin

EXPERIMENTAL

500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted

Drug: Daptomycin

Vancomycin

ACTIVE COMPARATOR

Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician

Drug: Vancomycin

Interventions

Daptomycin DRUG

Also known as: Cubicin

Daptomycin

Vancomycin DRUG

Vancomycin

Eligibility Criteria

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

You may qualify if:

• Complicated skin or skin structure infection (cSSSI)
• Intravenous vancomycin home infusion ordered for 7-14 days

You may not qualify if:

• Pregnant or lactating female
• Concurrently receiving other systemic antibiotics with gram positive activity
• Known or suspected allergy or hypersensitivity to daptomycin or vancomycin
• Known or suspected vancomycin-resistant enterococci (VRE)
• Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
• Known or suspected human immunodeficiency virus (HIV), cancer, or autoimmune disease such as lupus
• Receiving systemic concomitant immunosuppressive agents such as chemotherapy, corticosteroids, tacrolimus, sirolimus, or cyclosporine, during the duration of the study
• Requirement for non-study gram positive systemic antibiotics
• Known to be allergic or intolerant to intravenous vancomycin or daptomycin
• Participants with known or suspected creatinine clearance (CLcr) \< 30 milliliters per minute (mL/min)
• In skilled nursing facility
• In hospice or admission to hospice is planned

Sponsors & Collaborators

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

Study Sites (4)

Heartland I.V. Care

Livonia, Michigan, 48150, United States

Location

Heartland I.V. Care

Roseville, Minnesota, 55113, United States

Location

Heartland I.V. Care

Pittsburgh, Pennsylvania, 15220, United States

Location

NationsMed Clinical Research, Inc.

Stafford, Texas, 77477, United States

Location

MeSH Terms

Interventions

Daptomycin; Vancomycin

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Glycopeptides; Glycoconjugates; Carbohydrates

Limitations and Caveats

The study was terminated prematurely.

Results Point of Contact

• Title: Vice President, Clinical Research
• Organization: Cubist Pharmaceuticals

781-860-8318

Study Officials

• Paula Bokesch, MD

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: August 5, 2010
• Study Start: July 15, 2010
• Primary Completion: November 17, 2011
• Study Completion: November 17, 2011
• Last Updated: December 26, 2018
• Results First Posted: May 13, 2015

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

US (4)