Ideal Sample Volume for Blood CulturesNCT02468947
Finding Ideal Blood Culture Volume in NICU
An observational study of Ideal Sample Volume for Blood Cultures, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The investigators want to assess the effectivity of different sample volumes in blood cultures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ideal Sample Volume for Blood Cultures
- How many people
- 800 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Dec 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All babies treated in the neonatology department of the institution undergoing sepsis workup
Who may be able to join
- Suspected sepsis
Who cannot join
- Need for extra puncture in order to withdraw enough blood for the second set of cultures.
- Urgent need for antibiotic without time for cultures.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ruben Bromiker
Jerusalem, 91031
Ruben Bromiker, MD, 972508685154, bromi@smc.org.il
Yair Kasirer, MD, 972586476885, yairkasirer@yahoo.com
About this study
The investigators want to assess the effectivity of different sample volumes in blood cultures.
Read the detailed description
The investigators intend to compare yield of 0.5ml sample x2 vs 0.25 ml samples x2 (aerobic and anaerobic media for each volume) taken from the sample taken from the same site and time.
Time to positivity will also be compared, as well as possible contamination rates.
- Conditions
- Ideal Sample Volume for Blood Cultures
- Keywords
- Neonatal sepsis
- Medical subject headings
- Neonatal Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive blood cultures of each group
Measured: 2 years
Secondary outcomes (2)
Time to positivity for each group
Measured: 2 years
Suspected contamination rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startApr 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
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 Ideal Sample Volume for Blood CulturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bromiker, Ruben M.D, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468947
- Sponsor's protocol ID
- 182/14
- Status last verified
- Aug 2016
- First submitted
- 9 Jun 2015
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Yaacobi N, Bar-Meir M, Shchors I, Bromiker R. A prospective controlled trial of the optimal volume for neonatal blood cultures. Pediatr Infect Dis J. 2015 Apr;34(4):351-4. doi: 10.1097/INF.0000000000000594.
PubMed 25764096
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding Ideal Blood Culture Volume in NICU
- ClinicalTrials.gov ID
- NCT02468947
- Acronym / sponsor ID
- 182/14
- Conditions
- Ideal Sample Volume for Blood Cultures
- Keywords
- Neonatal sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Jun 2015 (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.
The investigators want to assess the effectivity of different sample volumes in blood cultures.
Detailed description
The investigators intend to compare yield of 0.5ml sample x2 vs 0.25 ml samples x2 (aerobic and anaerobic media for each volume) taken from the sample taken from the same site and time.
Time to positivity will also be compared, as well as possible contamination rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All babies treated in the neonatology department of the institution undergoing sepsis workup
Key inclusion criteria (1 listed)
- Suspected sepsis
Key exclusion criteria (2 listed)
- Need for extra puncture in order to withdraw enough blood for the second set of cultures.
- Urgent need for antibiotic without time for cultures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive blood cultures of each group
Time frame: 2 years
2 secondary outcomes
Time to positivity for each group
Time frame: 2 years
Suspected contamination rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Results publication: PubMed 25764096Yaacobi N, Bar-Meir M, Shchors I, Bromiker R. A prospective controlled trial of the optimal volume for neonatal blood cultures. Pediatr Infect Dis J. 2015 Apr;34(4):351-4. doi: 10.1097/INF.0000000000000594.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ideal Sample Volume for Blood Cultures, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive blood cultures of each group (time frame: 2 years). 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 NCT02468947, 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 9 Aug 2016.