BacteremiaNCT01023555
Increasing the Yield of Blood Cultures in Neonates
A study testing 1cc of blood in a single aerobic culture bottle in people with Bacteremia, run by Shaare Zedek Medical Center.
Trial summary
The purpose of this study is to determine whether the use of a single blood sample of 1cc in an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc in 2 (aerobic and anaerobic) bottles for blood cultures in neonates. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacteremia
- What is being tested?
- 1cc of blood in a single aerobic culture bottle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All blood cultures taken in the NICU during the study period.
Who cannot join
- Bacteria that are normal flora of the skin such as Coagulase negative staphylococci or Streptococci Viridans are considered, except if grown in two sets of cultures or in the presence of laboratory and clinical indices of infection.
About this study
Official title: Increasing the Yield of Blood Cultures in the Neonatal Intensive Care Unit- A Prospective Controlled Trial
The purpose of this study is to determine whether the use of a single blood sample of 1cc in an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc in 2 (aerobic and anaerobic) bottles for blood cultures in neonates.
- Conditions
- Bacteremia
- Being tested
- 1cc of blood in a single aerobic culture bottle
- Keywords
- Bacteremia, Blood Cultures, Sepsis
- Medical subject headings
- Bacteremia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1cc of blood in a single aerobic culture bottleOther
The efficacy of using 1cc of blood in a single aerobic bottle for cultures in neonatal bacteremia will will be compared with the traditional 0.5cc of blood in 2 Bottles
| Study group | Role | What they receive |
|---|---|---|
| 0.5cc 2 Bottles | No intervention | Not described |
| 1cc single bottle | Active comparator | Not described Receives: Other: 1cc of blood in a single aerobic culture bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles.
Measured: 6months
Secondary outcomes (2)
utility of the routine use of anaerobic bottle for blood cultures in newborns
Measured: 6 months
Comparison of time to positivity of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles (aerobic and anaerobic)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
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 BacteremiaStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023555
- Sponsor's protocol ID
- SZMC-bromi
- Status last verified
- Jul 2011
- First submitted
- 1 Dec 2009
- Last updated
- 26 Jul 2011
- 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 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Yield of Blood Cultures in the Neonatal Intensive Care Unit- A Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT01023555
- Acronym / sponsor ID
- SZMC-bromi
- Conditions
- Bacteremia
- Keywords
- Bacteremia, Blood Cultures, Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Dec 2009 (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 purpose of this study is to determine whether the use of a single blood sample of 1cc in an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc in 2 (aerobic and anaerobic) bottles for blood cultures in neonates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5cc 2 Bottles | No intervention | – |
| 1cc single bottle | Active comparator | Other: 1cc of blood in a single aerobic culture bottle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All blood cultures taken in the NICU during the study period.
Key exclusion criteria (1 listed)
- Bacteria that are normal flora of the skin such as Coagulase negative staphylococci or Streptococci Viridans are considered, except if grown in two sets of cultures or in the presence of laboratory and clinical indices of infection.
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 |
|---|---|---|
| 1cc of blood in a single aerobic culture bottleThe efficacy of using 1cc of blood in a single aerobic bottle for cultures in neonatal bacteremia will will be compared with the traditional 0.5cc of blood in 2 Bottles | Other | 1cc single bottle |
Primary outcome
Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles.
Time frame: 6months
2 secondary outcomes
utility of the routine use of anaerobic bottle for blood cultures in newborns
Time frame: 6 months
Comparison of time to positivity of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles (aerobic and anaerobic)
Time frame: 6 months
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 26 Jul 2011.
- Derived from this study: 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 1cc of blood in a single aerobic culture bottle in people with Bacteremia, run by Shaare Zedek Medical Center.
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 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles. (time frame: 6months). 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 NCT01023555, 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 26 Jul 2011.