Blood Culture Collection Strategies for Suspected Bloodstream Infection

NCT07751575 | Active Not Recruiting

• 1 other identifier: 0120-649/2025-2711-6
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Blood cultures are the reference standard for diagnosing bloodstream infections and are essential for the management of patients with suspected sepsis. Their diagnostic performance depends strongly on the total volume of blood collected, while each additional venipuncture may increase patient discomfort, staff workload, and the opportunity for contamination. This prospective diagnostic study will evaluate two blood culture collection strategies within the same adult participant. Consecutive patients with a clinical indication for blood culture collection will be enrolled at Izola General Hospital. During the initial venipuncture, two complete blood culture sets, consisting of two aerobic and two anaerobic bottles and approximately 40 mL of blood, will be collected. One additional set, consisting of one aerobic and one anaerobic bottle and approximately 20 mL of blood, will then be collected from a second venipuncture site during the same diagnostic episode, generally within 30-60 minutes according to routine clinical workflow. The diagnostic performance of the single-venipuncture strategy will be determined from the initial four bottles. The diagnostic performance of the sequential two-venipuncture strategy will be determined from all six bottles. Each participant will therefore serve as their own control. The primary outcome is the paired difference in detection of clinically significant bloodstream pathogens. Secondary outcomes include the incremental diagnostic yield of the additional set, contamination, overall positivity, time to positivity, and the distribution of pathogens and contaminants. The investigators hypothesize that the single-venipuncture strategy will identify most clinically significant bloodstream pathogens detected by the complete protocol, while the additional set will provide a measurable but limited incremental diagnostic yield.

Conditions

Bacteremia and Sepsis; Bloodstream Infection

Keywords

Blood culture; blood culture collection; venipuncture; diagnostic performance; bloodstream infection; diagnostic stewardship; bacteremia; sepsis; contamination

Outcome Measures

Primary Outcomes (1)

• Paired difference in detection of clinically significant bloodstream pathogens

  For each participant, detection of at least one clinically significant bloodstream pathogen using the initial four bottles collected during one venipuncture will be compared with detection using all six bottles collected during the complete sequential protocol. Results will be reported as paired proportions and the absolute paired difference with a 95% confidence interval.

  From initial collection through completion of the five-day blood culture incubation period

Secondary Outcomes (3)

• Incremental diagnostic yield of the additional blood culture set

  From initial collection through completion of the five-day blood culture incubation period

• Blood culture contamination

  From initial collection through completion of the five-day blood culture incubation period

• Overall blood culture positivity

  From initial collection through completion of the five-day blood culture incubation period

Study Arms (1)

Standardized Six-Bottle Blood Culture Collection

EXPERIMENTAL

All participants undergo an initial single venipuncture yielding four blood culture bottles, followed by an additional two-bottle set collected from a second venipuncture site during the same diagnostic episode, generally within 30-60 minutes. Diagnostic results from the initial four bottles are compared with results from all six bottles within the same participant.

Diagnostic Test: Standardized sequential blood culture collection

Interventions

Standardized sequential blood culture collection DIAGNOSTIC_TEST

Two aerobic and two anaerobic blood culture bottles, targeting approximately 40 mL of blood, are collected during the initial venipuncture. One additional aerobic and one anaerobic bottle, targeting approximately 20 mL, are collected from a different venipuncture site during the same diagnostic episode, generally within 30-60 minutes. The complete collection totals six bottles and approximately 60 mL of blood.

Standardized Six-Bottle Blood Culture Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Clinical indication for blood culture collection determined by the treating physician as part of routine care.
• Planned collection of peripheral blood cultures during the current diagnostic episode.
• Ability to complete the study collection protocol.
• Informed consent obtained in accordance with the ethics committee approval and institutional requirements.

You may not qualify if:

• Inability to obtain blood cultures from two separate peripheral venipuncture sites.
• A clinical condition in which the treating physician considers the additional blood collection inappropriate or unsafe.
• Inability to obtain the intended blood volume because of failed collection or premature discontinuation.
• Blood cultures collected exclusively through an intravascular catheter.
• Declined consent or withdrawal of permission for study participation or use of study data, where applicable.

Sponsors & Collaborators

• Izola General Hospital: lead
• University of Primorska: collaborator

Study Sites (1)

Izola General Hospital

Izola, Slovenia

Location

MeSH Terms

Conditions

Bacteremia; Sepsis

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mladen Gasparini

  Izola General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Samo Jeverica, MD, PhD

Model Details: Standardized sequential blood culture collection Two aerobic and two anaerobic blood culture bottles, targeting approximately 40 mL of blood, are collected during the initial venipuncture. One additional aerobic and one anaerobic bottle, targeting approximately 20 mL, are collected from a different venipuncture site during the same diagnostic episode, generally within 30-60 minutes. The complete collection totals six bottles and approximately 60 mL of blood.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)