Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device
|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: NCT02102087|
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : August 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Septicemia||Device: Initial Specimen Diversion Device (ISDD) Device: Lab standard practice (LSP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||971 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Initial Specimen Diversion Device (ISDD)
The ISDD will be used in conjunction with standard blood culture bottles.
Device: Initial Specimen Diversion Device (ISDD)
Active Comparator: Lab standard practice (LSP)
A standard blood culture kit will be used.
Device: Lab standard practice (LSP)
- Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) [ Time Frame: Baseline ]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.
- Occurrence rate of adverse device effects [ Time Frame: Baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102087
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|