Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
- Conditions
- Complicated Skin or Skin Structure Infection
- Interventions
- Registration Number
- NCT01175707
- Lead Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- 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.
- Detailed Description
This is a randomized, open-label, multi-center, phase 4 study. The overall goals of this study are to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of cSSSI due to Gram-positive bacteria in participants who are prescribed vancomycin for 7-14 days and who are planning to receive vancomycin in a home infusion setting. Study objectives include evaluation of clinical and resource utilization endpoints and economic analysis from the perspective of the home infusion provider.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
- Complicated skin or skin structure infection (cSSSI)
- Intravenous vancomycin home infusion ordered for 7-14 days
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vancomycin Vancomycin 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 Daptomycin Daptomycin 500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
- Primary Outcome Measures
Name Time Method 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 Day 1 up to Day 14 The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.
Reasons for Pharmacist Consultations During Home Infusion Therapy Day 1 up to Day 14 The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.
Percentage of Treatment Goals Met at End of Therapy Day 1 up to Day 14 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.Time Spent (Minutes) for Home Infusion Therapy Day 1 up to Day 14 Each participant is counted once per category. Avg=average; Admin=administer.
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy Day 1 up to Day 14 Each participant is counted once per category.
Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy Day 1 up to Day 14 The mean duration in home-infusion antibiotic therapy per participant is presented.
- Secondary Outcome Measures
Name Time Method 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 Type of interventions include Intravenous (IV) line replacement, IV line removal, IV line placement (post study therapy), Incision and drainage (wound), Incision and drainage (line), Debridement, Declotting procedure, and Blood draw.
Mean Number of Interventions Per Participant During Home Infusion Therapy Day 1 up to Day 14 Type of interventions include IV line replacement, IV line removal, IV line placement (post study therapy), incision and drainage (wound), incision and drainage (line), debridement, declotting procedure, and blood draw.
Number of Intervention Types During Home Infusion Therapy Day 1 up to Day 14 There may be more than one type of intervention per participant. A participant is counted only once for each category even if they had several instances of a given intervention.
Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy Day 1 up to Day 14 Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.
Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy Day 1 up to Day 14 Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.
Number of Laboratory Assessment Types During Home Infusion Therapy Day 1 up to Day 14 There may be more than one type of laboratory assessment per participant. A participant is counted only once for each category. Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant Day 1 up to Day 14 Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.
Trial Locations
- Locations (2)
Heartland I.V. Care
🇺🇸Pittsburgh, Pennsylvania, United States
NationsMed Clinical Research, Inc.
🇺🇸Stafford, Texas, United States