Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device
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
1 other identifier
interventional
971
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2014
CompletedFirst Posted
Study publicly available on registry
April 2, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedAugust 11, 2017
August 1, 2017
1.3 years
March 21, 2014
August 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline
Secondary Outcomes (1)
Occurrence rate of adverse device effects
Baseline
Study Arms (2)
Initial Specimen Diversion Device (ISDD)
EXPERIMENTALThe ISDD will be used in conjunction with standard blood culture bottles.
Lab standard practice (LSP)
ACTIVE COMPARATORA standard blood culture kit will be used.
Interventions
Eligibility Criteria
You may qualify if:
- Adults \>19 years old
You may not qualify if:
- Not a good candidate for direct-to-media (DTM) technique
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Related Publications (1)
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.
PMID: 28379370RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2014
First Posted
April 2, 2014
Study Start
July 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
August 11, 2017
Record last verified: 2017-08