Finding Ideal Blood Culture Volume in NICU

Ideal Sample Volume for Blood Cultures Clinical Trial

Official title:

Finding Ideal Blood Culture Volume in NICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02468947
• Other study ID #: 182/14
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2015
• Last updated: August 7, 2016
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The investigators want to assess the effectivity of different sample volumes in blood cultures.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Suspected sepsis

Exclusion Criteria:

• Need for extra puncture in order to withdraw enough blood for the second set of cultures.

• Urgent need for antibiotic without time for cultures.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ideal Sample Volume for Blood Cultures

Locations

Country	Name	City	State
Israel	Ruben Bromiker	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive blood cultures of each group		2 years	No
Secondary	Time to positivity for each group		2 years	No
Secondary	Suspected contamination rate		2 years	No