SepticemiaNCT03088865
Evaluation of an Internal Hospital Practice: The Effect of Altered Test Tubes Sampling Order on Blood Culture Contamination Rates
A study testing aspirating first blood volume into a regular blood collection tube in people with Septicemia, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Implementation of the initial specimen diversion technique, in which the first milliliter of the venipuncture sample is not injected into the culture bottle, led to a significant reduction in blood culture contamination rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septicemia
- What is being tested?
- aspirating first blood volume into a regular blood collection tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2017to 6 Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults evaluated in the emergency room or as inpatients for suspected sepsis or having sepsis and from whom the treating physician plans to take, in the same venous puncture, blood cultures and additional blood tests (blood count and/or blood chemistry).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Internal Hospital Practice: The Effect of Altered Sampling Protocol on Blood Culture Contamination Rates: An Open, Randomized, Prospective Study
Implementation of the initial specimen diversion technique, in which the first milliliter of the venipuncture sample is not injected into the culture bottle, led to a significant reduction in blood culture contamination rates. This technique is based on the assumption that the skin plug aspirated during venipuncture is a major source of contaminating bacteria. One such diversion method is aspirating the first blood volume into a blood collection tube. It has, however, been suggested that regular blood collection tubes carry contaminants from the tube's stopper into the blood cultures drawn afterwards, thereby increasing contamination rates. The aim of this trial is to examine the effect of aspirating the first blood volume into a regular blood collection tube on blood culture contamination rate.
- Conditions
- Septicemia
- Being tested
- aspirating first blood volume into a regular blood collection tube
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirating first blood volume into a regular blood collection tubeDiagnostic test
order of blood drawing
| Study group | Role | What they receive |
|---|---|---|
| Initial Specimen Diversion | Experimental | Aspirating first blood volume into a regular blood collection tube Receives: Diagnostic Test: aspirating first blood volume into a regular blood collection tube |
| Standard practice | Active comparator | Aspirating first blood into blood culture bottles (Standard practice) Receives: Diagnostic Test: aspirating first blood volume into a regular blood collection tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood culture contamination rate
A blood culture contamination is defined as growth in a single set of coagulase-negative Staphylococcus, Micrococcus, Viridans group Streptococcus, Propionibacterium acne, Corynebacterium sp (diphtheroids) or Bacillus sp.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Sep 2017
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepticemiaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088865
- Sponsor's protocol ID
- 0017-17-HMO
- Status last verified
- Feb 2020
- First submitted
- 9 Mar 2017
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lalezari A, Cohen MJ, Svinik O, Tel-Zur O, Sinvani S, Al-Dayem YA, Block C, Moses AE, Oster Y, Salameh S, Strahilevitz J. A simplified blood culture sampling protocol for reducing contamination and costs: a randomized controlled trial. Clin Microbiol Infect. 2020 Apr;26(4):470-474. doi: 10.1016/j.cmi.2019.09.005. Epub 2019 Sep 17.
PubMed 31539635
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Internal Hospital Practice: The Effect of Altered Sampling Protocol on Blood Culture Contamination Rates: An Open, Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT03088865
- Acronym / sponsor ID
- 0017-17-HMO
- Conditions
- Septicemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 23 Mar 2017 (actual)
- 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.
Implementation of the initial specimen diversion technique, in which the first milliliter of the venipuncture sample is not injected into the culture bottle, led to a significant reduction in blood culture contamination rates. This technique is based on the assumption that the skin plug aspirated during venipuncture is a major source of contaminating bacteria. One such diversion method is aspirating the first blood volume into a blood collection tube. It has, however, been suggested that regular blood collection tubes carry contaminants from the tube's stopper into the blood cultures drawn afterwards, thereby increasing contamination rates. The aim of this trial is to examine the effect of aspirating the first blood volume into a regular blood collection tube on blood culture contamination rate.
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 | Experimental | Diagnostic Test: aspirating first blood volume into a regular blood collection tubeAspirating first blood volume into a regular blood collection tube |
| Standard practice | Active comparator | Diagnostic Test: aspirating first blood volume into a regular blood collection tubeAspirating first blood into blood culture bottles (Standard practice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults evaluated in the emergency room or as inpatients for suspected sepsis or having sepsis and from whom the treating physician plans to take, in the same venous puncture, blood cultures and additional blood tests (blood count and/or blood chemistry).
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| aspirating first blood volume into a regular blood collection tubeorder of blood drawing | Diagnostic test | Initial Specimen Diversion, Standard practice |
Primary outcome
Blood culture contamination rate
Time frame: 7 days
A blood culture contamination is defined as growth in a single set of coagulase-negative Staphylococcus, Micrococcus, Viridans group Streptococcus, Propionibacterium acne, Corynebacterium sp (diphtheroids) or Bacillus sp.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 31539635Lalezari A, Cohen MJ, Svinik O, Tel-Zur O, Sinvani S, Al-Dayem YA, Block C, Moses AE, Oster Y, Salameh S, Strahilevitz J. A simplified blood culture sampling protocol for reducing contamination and costs: a randomized controlled trial. Clin Microbiol Infect. 2020 Apr;26(4):470-474. doi: 10.1016/j.cmi.2019.09.005. Epub 2019 Sep 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aspirating first blood volume into a regular blood collection tube in people with Septicemia, run by Hadassah Medical Organization at 1 site in Israel.
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: finished, as of the sponsor's last update on 29 Jul 2020. 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood culture contamination rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03088865, which also lists 1 linked publication.
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 29 Jul 2020.