Blood Culture Collection Strategies for Suspected Bloodstream Infection

Running, not enrolling · Not applicable

Conditions studied: Bacteremia and Sepsis, Bloodstream Infection

In brief

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.

Key facts

Study ID

NCT07751575

Run by

Izola General Hospital

People needed

3000

Starts

2026-08-01

Expected to finish

2028-01-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Izola General Hospital — Izola, Slovenia

Full record on ClinicalTrials.gov

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