SepticemiaNCT02093494
Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters
A study testing Initial Specimen Diversion Device (ISDD), Lab standard practice (LSP) and Peripheral Intravenous Catheters (PIVC) in people with Septicemia, run by Magnolia Medical Technologies, Inc. at 1 site in United States.
Trial summary
This is a randomized, 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.). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Septicemia
- What is being tested?
- Initial Specimen Diversion Device (ISDD), Lab standard practice (LSP) and Peripheral Intravenous Catheters (PIVC)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >19 years old
Who cannot join
- Not a good candidates for direct-to-media (DTM) technique
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Randomized, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination Compared to Laboratory Standard Procedures When Collected Through Peripheral Intravenous Catheters (PIVC)
This is a randomized, 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 PIVC's 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.
- Conditions
- Septicemia
- Being tested
- Initial Specimen Diversion Device (ISDD), Lab standard practice (LSP), Peripheral Intravenous Catheters (PIVC)
- Keywords
- Septicemia, Blood culture, Contamination
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial Specimen Diversion Device (ISDD)Device
Lab standard practice (LSP)Procedure or surgery
Peripheral Intravenous Catheters (PIVC)Device
| Study group | Role | What they receive |
|---|---|---|
| Initial Specimen Diversion Device (ISDD) | Experimental | The ISDD will be used to collect the blood culture. Receives: Device: Initial Specimen Diversion Device (ISDD) |
| Lab standard practice (LSP) | Active comparator | The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized. Receives: Procedure: Lab standard practice (LSP); Device: Peripheral Intravenous Catheters (PIVC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC
Measured: Baseline
Secondary outcomes (1)
Evaluate the occurrence of any 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. Any issues with the function of the device will be reported by the phlebotomist on a device incident form. The sponsor will maintain these reports in a database. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepticemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magnolia Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Patton, M.D., Study director, Magnolia Medical Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093494
- Sponsor's protocol ID
- MMT1303
- Status last verified
- Aug 2017
- First submitted
- 17 Mar 2014
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination Compared to Laboratory Standard Procedures When Collected Through Peripheral Intravenous Catheters (PIVC)
- ClinicalTrials.gov ID
- NCT02093494
- Acronym / sponsor ID
- MMT1303
- Conditions
- Septicemia
- Keywords
- Septicemia, Blood culture, Contamination
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Magnolia Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, 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 PIVC's 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Specimen Diversion Device (ISDD) | Experimental | Device: Initial Specimen Diversion Device (ISDD)The ISDD will be used to collect the blood culture. |
| Lab standard practice (LSP) | Active comparator | Procedure: Lab standard practice (LSP), Device: Peripheral Intravenous Catheters (PIVC)The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults >19 years old
Key exclusion criteria (1 listed)
- Not a good candidates for direct-to-media (DTM) technique
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial Specimen Diversion Device (ISDD) | Device | Initial Specimen Diversion Device (ISDD) |
| Lab standard practice (LSP) | Procedure or surgery | Lab standard practice (LSP) |
| Peripheral Intravenous Catheters (PIVC) | Device | Lab standard practice (LSP) |
Primary outcome
Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC
Time frame: Baseline
1 secondary outcome
Evaluate the occurrence of any adverse device effects
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Patton, M.D. study director
Magnolia Medical Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial Specimen Diversion Device (ISDD), Lab standard practice (LSP) and Peripheral Intravenous Catheters (PIVC) in people with Septicemia, run by Magnolia Medical Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.