Diagnostic Performance of Single-Venipuncture and Sequential Two-Venipuncture Blood Culture Collection Strategies in Adults With Suspected Bloodstream Infection: A Prospective Within-Participant Diagnostic Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Paired difference in detection of clinically significant bloodstream pathogens
研究概览
简要总结
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.
详细描述
Bloodstream infections are associated with substantial morbidity and mortality, particularly in patients with sepsis and septic shock. Timely identification of the causative microorganism enables targeted antimicrobial treatment and supports antimicrobial stewardship. Blood cultures remain the microbiological reference standard, but their performance is influenced by pre-analytical factors, particularly the total blood volume collected, the number of culture bottles, timing of collection, and contamination during venipuncture.
Conventional practice commonly involves collection of blood culture sets from two separate venipuncture sites. However, available evidence suggests that total blood volume may contribute more to pathogen detection than the number of venipunctures. Collecting multiple bottles during one venipuncture may simplify the procedure and improve compliance with the intended blood volume, whereas each additional venipuncture creates another opportunity for contamination. Prospective within-participant evidence from routine clinical settings remains limited.
This is a single-center, prospective, within-participant diagnostic study conducted at Izola General Hospital. Consecutive adults for whom the treating physician orders blood cultures as part of routine care will be assessed for eligibility. The clinical indication for blood culture collection and all treatment decisions will remain under the responsibility of the treating team.
During the initial venipuncture, two complete blood culture sets will be collected, comprising two aerobic and two anaerobic bottles with a target total blood volume of approximately 40 mL. During the same diagnostic episode, generally within 30-60 minutes and according to routine clinical workflow, an additional blood culture set comprising one aerobic and one anaerobic bottle with approximately 20 mL of blood will be collected from a different venipuncture site. The complete study collection will therefore consist of six bottles and approximately 60 mL of blood.
The initial four bottles will define the single-venipuncture strategy. All six bottles will define the sequential two-venipuncture strategy. Because both diagnostic strategies are reconstructed from specimens obtained from the same participant, participant-level clinical characteristics are held constant and each participant serves as their own control. The comparison evaluates the incremental contribution of the additional set and cannot separate the effect of the second venipuncture from the effect of the additional 20 mL of blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standardized Six-Bottle Blood Culture Collection
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.
干预措施: Standardized sequential blood culture collection (Diagnostic Test)
结局指标
主要结局
Paired difference in detection of clinically significant bloodstream pathogens
时间窗: From initial collection through completion of the five-day blood culture incubation period
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.
次要结局
- 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)
研究者
Samo Jeverica
Assoc. Prof. Samo Jeverica, MD, PhD
Izola General Hospital