Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections

• Sponsor: University of Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT01549613
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the Emergency Department (ED) treatment of complicated skin and skin structure infection in the Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who are admitted to the RDTC cellulitis protocol in the ED will be randomized to either vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or daptomycin, which is the experimental treatment in this study. The primary hypothesis is that daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.

Condition or Disease	Intervention/Treatment	Phase
Cellulitis; Skin Infections	Drug: Daptomycin; Drug: Vancomycin	Phase 4

Detailed Description

Specific Aim 1: Compare the efficacy of daptomycin to the efficacy of vancomycin for the treatment of complicated skin and skin structure infection in the ED. Patients eligible for the RDTC Cellulitis Treatment Protocol will be screened for inclusion in the study. After informed consent, patients will be randomized to receive either daptomycin or vancomycin (1:1 ratio). A case report form (CRF) detailing medical history, clinical characteristics, and treatments will be completed. The patients will be evaluated for meeting RDTC discharge criteria. The following time points will be collected: 1. actual time patient meets discharge criteria based on the RDTC cellulitis protocol; 2. time of disposition defined as the time treating physician writes discharge orders; and, 3. time the patient actually leaves the emergency department. Subsequently, the patient will be followed up by telephone to ascertain whether a change in antibiotic therapy or a return ED visit for complicated skin and skin structure infection occurred within 30 days of the initial RDTC enrollment Specific Aim 2: Compare the change in area and erythema of the cellulitic lesion between patients treated with daptomycin and patients treated with vancomycin. Patients enrolled in the study will have serial digital photographs of their primary lesion taken. The images will be processed blinded to clinical data and asynchronous to the ED stay. The change in lesion area and erythema will be calculated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: standard treatment with daptomycin Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol	Drug: Daptomycin; • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
Active Comparator: standard treatment of vancomycin Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.	Drug: Vancomycin; • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.

Outcome Measures

Primary Outcome Measures

1. Satisfaction of Discharge Criteria [Time point at which outcome measure is assessed 30 days from the date of admission.]

   RDTC cellulitis protocol discharge criteria

Secondary Outcome Measures

1. Digital and Infrared Imaging [Time frame begins on admission to RDTC for cellulitis and measurements will be taken every 2hour times 2 and every 4 hours until discharge from the RDTC.]

   Change in lesion area and temperature

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Admitted to RDTC to the Cellulitis Protocol

• 18 yrs old or greater

• Able and willing to give informed consent

• Hemodynamically stable (systolic blood pressure >90mmHg and heart rate <120 beats per minute)

Exclusion Criteria:

• Antibiotics given prior to enrollment

• Suspected necrotizing infection

• Diabetic foot ulcer

• Genitourinary involvement

• Post operative infection (not including simple wound closure infection)

• Suspected gouty or septic arthritis

• Chronic Lymphangitis

• Requiring routine hemodialysis

• Patient reported allergy to Vancomycin

• Patient reported allergy to Daptomycin

• Participation in another investigational treatment study within 30 days prior to enrollment

• Prisoner

• Pregnant or breast-feeding

• Complicated skin and skin structure infection of the face

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati, Dept. of Emergency Medicine	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

• University of Cincinnati

Investigators

• Principal Investigator: George J. Shaw, MD, PhD, University of Cincinnati, Dept. of Emergency Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: George Shaw, Associate Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT01549613
• Other Study ID Numbers: 11-11-03-06
• First Posted: Mar 9, 2012
• Last Update Posted: Aug 1, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Emergencies; Vancomycin; Daptomycin

Study Results

Participant Flow

Arm/Group Title	Standard Treatment With Daptomycin	Standard Treatment of Vancomycin
Arm/Group Description	Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.	Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours. Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Period Title: Overall Study
STARTED	50	50
COMPLETED	39	39
NOT COMPLETED	11	11

Baseline Characteristics

Arm/Group Title	Standard Treatment With Daptomycin	Standard Treatment of Vancomycin	Total
Arm/Group Description	Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.	Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours. Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42 (12)	38 (13)	40 (12.5)
Sex: Female, Male (Count of Participants)
Female	21 42%	15 30%	36 36%
Male	29 58%	35 70%	64 64%
Race (NIH/OMB) (participants) [Number]
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	20 40%	14 28%	34 34%
White	29 58%	34 68%	63 63%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Satisfaction of Discharge Criteria
Description	RDTC cellulitis protocol discharge criteria
Time Frame	Time point at which outcome measure is assessed 30 days from the date of admission.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Treatment With Daptomycin	Standard Treatment of Vancomycin
Arm/Group Description	Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.	Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours. Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Measure Participants	50	50
Number [participants]	15 30%	14 28%

2. Secondary Outcome

Title	Digital and Infrared Imaging
Description	Change in lesion area and temperature
Time Frame	Time frame begins on admission to RDTC for cellulitis and measurements will be taken every 2hour times 2 and every 4 hours until discharge from the RDTC.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Standard Treatment With Daptomycin		Standard Treatment of Vancomycin
Arm/Group Description	Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.		Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours. Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
All Cause Mortality
	Standard Treatment With Daptomycin		Standard Treatment of Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Treatment With Daptomycin		Standard Treatment of Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Standard Treatment With Daptomycin		Standard Treatment of Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/50 (8%)		7/50 (14%)
General disorders
scheduled surgery for ovarian cyst	1/50 (2%)	1	0/50 (0%)	0
Returned to pmc for HPT and Diabetes	1/50 (2%)	1	0/50 (0%)	0
Investigations
hospital readmission	1/50 (2%)	1	2/50 (4%)	2
Respiratory, thoracic and mediastinal disorders
Red streak	0/50 (0%)	0	1/50 (2%)	1
Skin and subcutaneous tissue disorders
redman syndrome	0/50 (0%)	0	1/50 (2%)	1
Sought treatment of town	0/50 (0%)	0	1/50 (2%)	1
hives	1/50 (2%)	1	0/50 (0%)	0
Iv infiltrated	0/50 (0%)	0	1/50 (2%)	1
dog bite	0/50 (0%)	0	1/50 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.