Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01523899
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Larissa May, George Washington University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Cutaneous Abscess
Interventions Device: Xpert MRSA/SA SSTI
Diagnostic Test: Standard culture
Enrollment 252
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Xpert MRSA/SA SSTI Standard Culture
Hide Arm/Group Description Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay Standard bacterial culture and susceptibility testing
Period Title: Overall Study
Started 126 126
Completed 126 126
Not Completed 0 0
Arm/Group Title Xpert MRSA/SA SSTI Standard Culture Total
Hide Arm/Group Description Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay Total of all reporting groups
Overall Number of Baseline Participants 126 126 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 126 participants 252 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
126
 100.0%
126
 100.0%
252
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 126 participants 252 participants
36  (13.4) 36.5  (13.8) 36  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 126 participants 252 participants
Female
63
  50.0%
73
  57.9%
136
  54.0%
Male
63
  50.0%
53
  42.1%
116
  46.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 126 participants 126 participants 252 participants
126 126 252
1.Primary Outcome
Title Number of Participants With Antibiotic Usage at the Time of the ED Visit
Hide Description Number of Participants with Antibiotic Usage at the time of the ED visit (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xpert MRSA/SA SSTI Standard Culture
Hide Arm/Group Description:
Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
Overall Number of Participants Analyzed 126 126
Measure Type: Count of Participants
Unit of Measure: Participants
97
  77.0%
96
  76.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xpert MRSA/SA SSTI, Standard Culture
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.145
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Participant Clinical Improvement Post-treatment at One Week
Hide Description clinical improvement (decreasing erythema, pain, swelling, drainage, and presence or absence of fever) will be documented at 2-7 day phone follow up and 1 and 3 months
Time Frame 2 to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xpert MRSA/SA SSTI Standard Culture
Hide Arm/Group Description:
Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
Standard bacterial culture and susceptibility testing
Overall Number of Participants Analyzed 103 103
Measure Type: Count of Participants
Unit of Measure: Participants
91
  88.3%
94
  91.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xpert MRSA/SA SSTI, Standard Culture
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Clinical Outcome at One or Three Months
Hide Description Recurrence of abscess within a three month time period
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xpert MRSA/SA SSTI Standard Culture
Hide Arm/Group Description:
Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
Standard bacterial culture and susceptibility testing
Overall Number of Participants Analyzed 91 88
Measure Type: Count of Participants
Unit of Measure: Participants
26
  28.6%
24
  27.3%
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not expected with this diagnostic study and were not monitored for this study.
 
Arm/Group Title Xpert MRSA/SA SSTI Standard Culture
Hide Arm/Group Description Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay Xpert MRSA/SA SSTI: Use of Xpert MRSA/SA SSTI assay
All-Cause Mortality
Xpert MRSA/SA SSTI Standard Culture
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Xpert MRSA/SA SSTI Standard Culture
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Xpert MRSA/SA SSTI Standard Culture
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Larissa May, MD
Organization: University of California-Davis
Phone: 9167345000
EMail: lsmay@ucdavis.edu
Layout table for additonal information
Responsible Party: Larissa May, George Washington University
ClinicalTrials.gov Identifier: NCT01523899     History of Changes
Other Study ID Numbers: 030927
First Submitted: January 26, 2012
First Posted: February 1, 2012
Results First Submitted: February 23, 2017
Results First Posted: September 6, 2017
Last Update Posted: September 6, 2017