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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01175707

Enrollment

Registered

2010-08-05

Start date

2010-07-15

Completion date

2011-11-17

Last updated

2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complicated Skin or Skin Structure Infection

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.

Interventions

DRUGDaptomycin

DRUGVancomycin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.

Secondary

Measure	Time frame	Description
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	40
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.	40
Total	80

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	4	6

Baseline characteristics

Characteristic	Daptomycin	Vancomycin	Total
Age, Continuous	58.55 years STANDARD_DEVIATION 14.387	56.78 years STANDARD_DEVIATION 19.366	57.665 years STANDARD_DEVIATION 16.8765
Sex: Female, Male Female	19 Participants	21 Participants	40 Participants
Sex: Female, Male Male	21 Participants	19 Participants	40 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	13 / 40	5 / 40
serious Total, serious adverse events	7 / 40	7 / 40