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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
80
Heartland I.V. Care
Livonia, Michigan, United States
Heartland I.V. Care
Roseville, Minnesota, United States
Heartland I.V. Care
Pittsburgh, Pennsylvania, United States
NationsMed Clinical Research, Inc.
Stafford, Texas, United States
Time Spent (Minutes) for Home Infusion Therapy
Each participant is counted once per category. Avg=average; Admin=administer.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 up to Day 14
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
Time frame: Day 1 up to Day 14
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 up to Day 14
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.
Time frame: Day 1 up to Day 14
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.
Time frame: Day 1 up to Day 14
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.
Time frame: Day 1 up to Day 14
Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.
Time frame: Day 1 up to Day 14
Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.
Time frame: Day 1 up to Day 14
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
Time frame: Day 1 up to Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Day 1 up to Day 14