Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA (DAPHEOR1006)
|ClinicalTrials.gov Identifier: NCT01419184|
Recruitment Status : Completed
First Posted : August 18, 2011
Results First Posted : July 8, 2015
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Staphylococcal Skin Infections||Drug: Daptomycin Drug: Vancomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study to Evaluate Comparative Effectiveness, Inpatient Resource Utilization, and Cost of Daptomycin vs. Vancomycin in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Documented Methicillin-resistant Staphylococcus Aureus (MRSA)|
|Actual Study Start Date :||September 9, 2011|
|Primary Completion Date :||September 1, 2012|
|Study Completion Date :||October 5, 2012|
4 milligrams per kilogram (mg/kg) daptomycin administered intravenously (IV) once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
Other Name: Cubicin
Active Comparator: Vancomycin
Vancomycin was reconstituted per the manufacturer's instructions and was dosed per investigator's discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion
- Infection-Related Hospital Length of Stay [ Time Frame: Baseline (Day 0) through the End of Hospital Stay (up to Day 14) ]Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented.
- Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Baseline (Day 0), End of Hospital Stay (up to Day 14) ]Pain was measured as the amount of pain experienced "right now" by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain.
- Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL) [ Time Frame: Baseline (Day 0), End of Hospital Stay (up to Day 14) ]Health-related quality of life (HRQoL) was measured using the EuroQol-5 Dimensions, 5 Level (EQ-5D-5L) multi-attribute questionnaire. The 5 dimensions measured were: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant's health state was expressed by a descriptive profile of a 5 digit number. The EQ-5D health states were converted into a single summary index (from 0 to 1, with 0 representing death, to 1 representing perfect health) by applying weights to each of the levels in each dimension. Change from baseline to hospital discharge is presented; positive values represent an increase in health utility.
- Participant Global Impression of Improvement (PGI-I) at Hospital Discharge [ Time Frame: End of Hospital Stay (up to Day 14) ]PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement.
- 30-day cSSSI-related Hospital Readmission Rates [ Time Frame: End of Hospital Stay (up to Day 14) through 30 days post hospital discharge ]Hospital readmission rates were defined as readmission to an inpatient hospital facility within 30 days of hospital discharge for management of cSSSI relapse or treatment of adverse events related to cSSSI treatment. It did not include all-cause readmissions (for completeness, all-cause readmissions are reported in the descriptive tables). Participants were asked if they had been readmitted to the hospital since their discharge and whether the admission was specifically for their skin infection. The number of participants who were re-hospitalized for skin infection or side effects due to skin infection medication within 30 days since the initial hospital discharge (Day 14) is presented.
- cSSSI-related Medical Resource Utilization and Costs [ Time Frame: Baseline (Day 0) through 30 days post hospital discharge ]Direct medical costs were based on utilization of health resources. Unit cost data were obtained from sources external to the trial and assigned to corresponding medical resource utilization observed within the trial to estimate costs of care. cSSSI-related costs were reported from a societal perspective, and further broken down into a health care system perspective. The health care system perspective includes hospital and outpatient costs. The societal perspective includes the health care system perspective plus participant and caregiver time loss from work and participant and caregiver out-of-pocket expenses. Total cost (including both total inpatient and total post-discharge costs) per participant is presented.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419184
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|Study Director:||Cubist Pharmaceuticals Medical Monitor Medical Monitor||Cubist Pharmaceuticals LLC|