Loading
Standardized sequential blood culture collection / Bacteremia and Sepsis / Bloodstream Infection · Interventional Study
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective paired diagnostic study registered to compare single-venipuncture (two sets, ~40 mL) versus sequential two-venipuncture (three sets, ~60 mL total) blood culture collection strategies in suspected sepsis. No results have been posted to the registry; the study is active but not recruiting. The primary outcome is paired difference in detection of clinically significant bloodstream pathogens over a five-day incubation period.
Interventional, Single Group, Open label, Diagnostic purpose. Bacteremia and Sepsis, Bloodstream Infection; age from 18 Years. Intervention: Standardized Six-Bottle Blood Culture Collection. Compared with: Single-venipuncture strategy (initial four bottles only) evaluated within the same participant.. n = 3,000. 1 site: Slovenia.
This is a prospective paired diagnostic study registered to compare single-venipuncture (two sets, ~40 mL) versus sequential two-venipuncture (three sets, ~60 mL total) blood culture collection strategies in suspected sepsis. No results have been posted to the registry; the study is active but not recruiting. The primary outcome is paired difference in detection of clinically significant bloodstream pathogens over a five-day incubation period.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study will inform whether a single venipuncture collecting 40 mL across four bottles captures most clinically significant pathogens, potentially reducing patient discomfort and contamination risk compared to sequential collection. Results should guide evidence-based blood culture protocols in sepsis workup once outcomes are published.
This is an active registry record for a prospective diagnostic study with no results posted; the planned design is sound but evidence cannot be evaluated until outcomes are reported.
As stated by the source record.
Quoted from the source exactly as published.
This study will inform whether a single venipuncture collecting 40 mL across four bottles captures most clinically significant pathogens, potentially reducing patient discomfort and contamination risk compared to sequential collection. Results should guide evidence-based blood culture protocols in sepsis workup once outcomes are published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07751575). This is a study registration, not published results. Lead sponsor: Izola General Hospital. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 3000 participants (ESTIMATED). Conditions: Bacteremia and Sepsis, Bloodstream Infection. Interventions: DIAGNOSTIC_TEST: Standardized sequential blood culture collection. Primary outcome measures: Paired difference in detection of clinically significant bloodstream pathogens , From initial collection through completion of the five-day blood culture incubation period. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.