Blood Culture ContaminationNCT03966534
Blood Test Order and Culture Contamination
A study testing Blood diversion in people with Blood Culture Contamination, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
A randomized partially controlled study to examine the effect of blood diversion into a heparin lithium tube on the incidence of blood culture contamination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Culture Contamination
- What is being tested?
- Blood diversion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 970 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2018to 28 Feb 2019
- 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
- Age > 18
- Presence in Emergency Room during extended office hours (0800-2000 on weekdays(
- Clinical requirement for Blood culture and biochemistry tests from venepuncture
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study of Blood Test Draw Order to Reduce Blood Culture Contamination
A randomized partially controlled study to examine the effect of blood diversion into a heparin lithium tube on the incidence of blood culture contamination.
- Conditions
- Blood Culture Contamination
- Being tested
- Blood diversion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood diversionOther
Diversion of initial blood obtained at venipuncture to biochemistry tube in order to try and reduce incidence of blood culture contamination
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Blood culture obtained as first test after venipuncture and prior to biochemistry test |
| Diversion Group | Experimental | Biochemistry test obtained as first test after venepuncture and prior to blood culture Receives: Other: Blood diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood culture contamination
Growth of bacteria defined as blood culture contaminants (for example coagulase negative staphylococci in one bottle only).
Measured: up to 7 days from obtaining blood culture
Secondary outcomes (1)
Patient length of stay
Length of stay from arrival at Emergency room until discharge in hours
Measured: up to 3 months from arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Sep 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
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 Blood Culture ContaminationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective partially blinded randomized study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 970 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966534
- Sponsor's protocol ID
- 0177-18-SZMC
- Status last verified
- Sep 2018
- First submitted
- 21 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zimmerman FS, Karameh H, Ben-Chetrit E, Zalut T, Assous M, Levin PD. Modification of Blood Test Draw Order to Reduce Blood Culture Contamination: A Randomized Clinical Trial. Clin Infect Dis. 2020 Aug 22;71(5):1215-1220. doi: 10.1093/cid/ciz971.
PubMed 31570942
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Blood Test Draw Order to Reduce Blood Culture Contamination
- ClinicalTrials.gov ID
- NCT03966534
- Acronym / sponsor ID
- 0177-18-SZMC
- Conditions
- Blood Culture Contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 970 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 29 May 2019 (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.
A randomized partially controlled study to examine the effect of blood diversion into a heparin lithium tube on the incidence of blood culture contamination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective partially blinded randomized study
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Blood culture obtained as first test after venipuncture and prior to biochemistry test |
| Diversion Group | Experimental | Other: Blood diversionBiochemistry test obtained as first test after venepuncture and prior to blood culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Presence in Emergency Room during extended office hours (0800-2000 on weekdays(
- Clinical requirement for Blood culture and biochemistry tests from venepuncture
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 |
|---|---|---|
| Blood diversionDiversion of initial blood obtained at venipuncture to biochemistry tube in order to try and reduce incidence of blood culture contamination | Other | Diversion Group |
Primary outcome
Blood culture contamination
Time frame: up to 7 days from obtaining blood culture
Growth of bacteria defined as blood culture contaminants (for example coagulase negative staphylococci in one bottle only).
1 secondary outcome
Patient length of stay
Time frame: up to 3 months from arrival
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 May 2019.
- Derived from this study: PubMed 31570942Zimmerman FS, Karameh H, Ben-Chetrit E, Zalut T, Assous M, Levin PD. Modification of Blood Test Draw Order to Reduce Blood Culture Contamination: A Randomized Clinical Trial. Clin Infect Dis. 2020 Aug 22;71(5):1215-1220. doi: 10.1093/cid/ciz971.
- Individual participant dataSharing planned: No
Related trials for Blood Culture Contamination
Active, not recruiting
Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)
Blood Culture Contamination, Infection
RecruitingObservational study
Impact of Blood Cultures Drawn From Arterial Lines on the Incidence of Contamination, Detection of Bacteremia, and Blood Culture Volume
Bacteremia
Active, not recruiting
Blood Culture Collection Strategies for Suspected Bloodstream Infection
Bacteremia and Sepsis, Bloodstream Infection
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 Blood diversion in people with Blood Culture Contamination, run by Shaare Zedek Medical Center 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 3 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 May 2019. 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 (time frame: up to 7 days from obtaining blood culture). 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 NCT03966534, 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 May 2019.