Complicated Skin or Skin Structure InfectionPhase 4NCT01175707
Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting
A Phase 4 study testing Daptomycin and Vancomycin in people with Complicated Skin or Skin Structure Infection, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Skin or Skin Structure Infection
- What is being tested?
- Daptomycin and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jul 2010to 17 Nov 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complicated skin or skin structure infection (cSSSI)
- Intravenous vancomycin home infusion ordered for 7-14 days
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Heartland I.V. Care
Livonia, Michigan, 48150
Heartland I.V. Care
Pittsburgh, Pennsylvania, 15220
Heartland I.V. Care
Roseville, Minnesota, 55113
NationsMed Clinical Research, Inc.
Stafford, Texas, 77477
About this study
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
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.
Read the 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.
- Being tested
- Daptomycin, Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
VancomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent (Minutes) for Home Infusion Therapy
Each participant is counted once per category. Avg=average; Admin=administer.
Measured: 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.
Measured: 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.
Measured: Day 1 up to Day 14
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
Measured: Day 1 up to Day 14
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 1 up to Day 14
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.
Measured: Day 1 up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study start15 Jul 2010
- Primary completion17 Nov 2011
- Study completion17 Nov 2011
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complicated Skin or Skin Structure InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paula Bokesch, MD, Study director, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175707
- Sponsor's protocol ID
- 3009-009
- Other IDs
- DAP-4HOME-09-05
- Status last verified
- Dec 2018
- First submitted
- 20 Jul 2010
- Last updated
- 26 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01175707
- Acronym / sponsor ID
- 3009-009
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2010 (actual)
- Primary completion
- 17 Nov 2011 (actual)
- Study completion
- 17 Nov 2011 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Posted 13 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daptomycin | Experimental | Drug: Daptomycin500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted |
| Vancomycin | Active comparator | Drug: VancomycinVancomycin 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complicated skin or skin structure infection (cSSSI)
- Intravenous vancomycin home infusion ordered for 7-14 days
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaptomycinAlso: Cubicin | Drug | Daptomycin |
| Vancomycin | Drug | Vancomycin |
Primary outcome
Time Spent (Minutes) for Home Infusion Therapy
Time frame: 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
Time frame: 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
Time frame: 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
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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy
Time frame: Day 1 up to Day 14
Mean Number of Interventions Per Participant During Home Infusion Therapy
Time frame: Day 1 up to Day 14
Number of Intervention Types During Home Infusion Therapy
Time frame: Day 1 up to Day 14
Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
Time frame: Day 1 up to Day 14
Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
Time frame: Day 1 up to Day 14
Number of Laboratory Assessment Types During Home Infusion Therapy
Time frame: Day 1 up to Day 14
Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Time frame: Day 1 up to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Bokesch, MD study director
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daptomycin and Vancomycin in people with Complicated Skin or Skin Structure Infection, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Spent (Minutes) for Home Infusion Therapy (time frame: Day 1 up to Day 14). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.