Back to resultsStudy to Evaluate the Effectiveness of the Initial Specimen Diversion Device
Primary Purpose
Septicemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Initial Specimen Diversion Device (ISDD)
Lab standard practice (LSP)
Sponsored by
About this trial
This is an interventional diagnostic trial for Septicemia
Eligibility Criteria
Inclusion Criteria:
- Adults >19 years old
Exclusion Criteria:
- Not a good candidate for direct-to-media (DTM) technique
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Initial Specimen Diversion Device (ISDD)
Lab standard practice (LSP)
Arm Description
The ISDD will be used in conjunction with standard blood culture bottles.
A standard blood culture kit will be used.
Outcomes
Primary Outcome Measures
Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP)
Comparison of contamination for each clinical episode. The proportions of discordant contamination episodes will be compared between the Initial Specimen Diversion Device and Lab Standard Practice using McNemar's test.
Secondary Outcome Measures
Occurrence rate of adverse device effects
As the device under study enhances the blood diversion procedure during blood culture collection, and is part of standard blood collection standards, adverse device effects are not expected as a result of use of this device, but shall be recorded consistent with the adverse event definitions found in 21 CFR 812. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.
Full Information
NCT ID
NCT02102087
First Posted
March 21, 2014
Last Updated
August 9, 2017
Sponsor
Magnolia Medical Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02102087
Brief Title
Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device
Official Title
A Matched, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination When Compared to Laboratory Standard Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Magnolia Medical Technologies, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a matched, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via peripheral venipuncture may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septicemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
971 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Initial Specimen Diversion Device (ISDD)
Arm Type
Experimental
Arm Description
The ISDD will be used in conjunction with standard blood culture bottles.
Arm Title
Lab standard practice (LSP)
Arm Type
Active Comparator
Arm Description
A standard blood culture kit will be used.
Intervention Type
Device
Intervention Name(s)
Initial Specimen Diversion Device (ISDD)
Intervention Type
Device
Intervention Name(s)
Lab standard practice (LSP)
Primary Outcome Measure Information:
Title
Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP)
Description
Comparison of contamination for each clinical episode. The proportions of discordant contamination episodes will be compared between the Initial Specimen Diversion Device and Lab Standard Practice using McNemar's test.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Occurrence rate of adverse device effects
Description
As the device under study enhances the blood diversion procedure during blood culture collection, and is part of standard blood collection standards, adverse device effects are not expected as a result of use of this device, but shall be recorded consistent with the adverse event definitions found in 21 CFR 812. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults >19 years old
Exclusion Criteria:
Not a good candidate for direct-to-media (DTM) technique
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28379370
Citation
Rupp ME, Cavalieri RJ, Marolf C, Lyden E. Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device. Clin Infect Dis. 2017 Jul 15;65(2):201-205. doi: 10.1093/cid/cix304.
Results Reference
result
Learn more about this trial
Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device
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