Complicated Skin or Skin Structure Infection Clinical Trial
Official title:
A Phase 4, Prospective, Randomized, Open-label Study to Compare Use of Cubicin With Vancomycin Administered Intravenously in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Confirmed Gram-positive Bacteria in a Home Infusion Setting
| Verified date | December 2018 |
| Source | Cubist Pharmaceuticals LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 80 |
| Est. completion date | November 17, 2011 |
| Est. primary completion date | November 17, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Complicated skin or skin structure infection (cSSSI) - Intravenous vancomycin home infusion ordered for 7-14 days Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Heartland I.V. Care | Livonia | Michigan |
| United States | Heartland I.V. Care | Pittsburgh | Pennsylvania |
| United States | Heartland I.V. Care | Roseville | Minnesota |
| United States | NationsMed Clinical Research, Inc. | Stafford | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Cubist Pharmaceuticals LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time Spent (Minutes) for Home Infusion Therapy | Each participant is counted once per category. Avg=average; Admin=administer. | Day 1 up to Day 14 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy | Day 1 up to Day 14 | ||
| Primary | Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy | Day 1 up to Day 14 | ||
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy | 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. | Day 1 up to Day 14 | |
| Secondary | Mean Number of Interventions Per Participant During Home Infusion Therapy | 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. | Day 1 up to Day 14 | |
| Secondary | Number of Intervention Types During Home Infusion Therapy | 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. | Day 1 up to Day 14 | |
| Secondary | Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy | Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough. | Day 1 up to Day 14 | |
| Secondary | Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy | Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough. | Day 1 up to Day 14 | |
| Secondary | Number of Laboratory Assessment Types During Home Infusion Therapy | 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 | Day 1 up to Day 14 | |
| Secondary | Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant | Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing. | Day 1 up to Day 14 |