NCT01419184: DAPHEOR1006

Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

Completed Phase 4 Results posted Last updated 5 September 2018

What this trial tests

Phase 4 trial testing Daptomycin in Staphylococcal Skin Infections in 250 participants. Completed in 5 October 2012.

Timeline

9 September 2011

Primary endpoint
1 September 2012

5 October 2012

Quick facts

Lead sponsor	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	250
Start date	9 September 2011
Primary completion	1 September 2012
Estimated completion	5 October 2012
Sites	26 locations across Puerto Rico, United States

Drugs / interventions tested

• Daptomycin (Daptomycin) — full drug profile →
• Vancomycin (vancomycin) — full drug profile →

Conditions studied

• Staphylococcal Skin Infections — all drugs for Staphylococcal Skin Infections →

Sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

18 and older, any sex, with Staphylococcal Skin Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Infection-Related Hospital Length of Stay Primary · 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.

Group	Value	95% CI
Daptomycin	91.46	± 57.81
Vancomycin	93.23	± 60.78

Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF) Secondary · 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.

Group	Value	95% CI
Daptomycin	-2.08	± 3.13
Vancomycin	-2.54	± 3.46

Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL) Secondary · 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; pos

Group	Value	95% CI
Daptomycin	0.12	± 0.20
Vancomycin	0.18	± 0.21

Participant Global Impression of Improvement (PGI-I) at Hospital Discharge Secondary · 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.

Group	Value	95% CI
Daptomycin	2.05	± 1.16
Vancomycin	1.80	± 0.94

30-day cSSSI-related Hospital Readmission Rates Secondary · 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

Group	Value	95% CI
Daptomycin	5
Vancomycin	2

cSSSI-related Medical Resource Utilization and Costs Secondary · 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-o

Health Care System Perspective

Group	Value	95% CI
Daptomycin	10441.30	± 7952.40
Vancomycin	9894.34	± 6620.51

Societal Perspective

Group	Value	95% CI
Daptomycin	11085.57	± 8120.20
Vancomycin	10397.24	± 6827.55

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Daptomycin

Serious: 15/118 (13%)

Deaths: —

Vancomycin

Serious: 9/106 (8%)

Deaths: —

Serious adverse events (24 terms)

Reaction	System	Daptomycin	Vancomycin
Pneumonia	Infections and infestations	—	—
Atrial Fibrillation	Blood and lymphatic system disorders	—	—
cardiac arrest	Cardiac disorders	—	—
Sinus bradycardia	Cardiac disorders	—	—
Lyme infection, Lyme disease	General disorders	—	—
Allergic reaction (dermatologic)	Immune system disorders	—	—
Osteomyelitis, Foot	Infections and infestations	—	—
Worsening infection to left hand due to non-compliance	Infections and infestations	—	—
Right prepatella bursitis with abscess, Bursitis infective	Infections and infestations	—	—
Acute Viral Syndrome	Infections and infestations	—	—
Bilat Lower Extrem Cellulitis, Cellulitis of legs	Infections and infestations	—	—
Chest Wall infection status post right breast implant removal	Infections and infestations	—	—
Clinical worsening of right below knee stump infection	Infections and infestations	—	—
Left hallux osteomyelitis	Infections and infestations	—	—
Osteomyelitis	Infections and infestations	—	—
Osteomyelitis with septic arthritis	Infections and infestations	—	—
Right Leg Cellulitis	Infections and infestations	—	—
Seizure	Nervous system disorders	—	—
altered mental status	Psychiatric disorders	—	—
respiratory failure	Renal and urinary disorders	—	—
Renal insufficiency	Renal and urinary disorders	—	—
Shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—
red man syndrome	Skin and subcutaneous tissue disorders	—	—
social admission for reassignment of nursing home	Social circumstances	—	—

Most-reported serious reactions: Pneumonia, Atrial Fibrillation, cardiac arrest, Sinus bradycardia, Lyme infection, Lyme disease, Allergic reaction (dermatologic), Osteomyelitis, Foot, Worsening infection to left hand due to non-compliance.

Data from ClinicalTrials.gov NCT01419184 adverse events section.

Sponsor's own description

This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of this study is to compare infection-related hospital length of stay, along with a number of participant-reported outcomes, between participants with complicated skin and soft tissue infection treated with daptomycin and vancomycin.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antimicrobial Peptides and Cell-Penetrating Peptides: Non-Antibiotic Membrane-Targeting Strategies Against Bacterial Infections.
   Huang X, Li G. · · 2023 · cited 30× · PMID 36879855 · DOI 10.2147/idr.s396566
2. An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection.
   Kauf TL, McKinnon P, Corey GR, Bedolla J, et al · · 2015 · cited 19× · PMID 26547411 · DOI 10.1186/s12879-015-1261-9