Bacteremia and SepsisSIMPLE-BCNCT07751575
Blood Culture Collection Strategies for Suspected Bloodstream Infection
A study testing Standardized sequential blood culture collection in people with Bacteremia and Sepsis and Bloodstream Infection, run by Izola General Hospital at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia and Sepsis, Bloodstream Infection
- What is being tested?
- Standardized sequential blood culture collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Aug 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
All bottles will be transported, incubated for five days, and processed according to routine microbiology laboratory procedures. Positive cultures will undergo microorganism identification and antimicrobial susceptibility testing when clinically indicated. Isolates will be classified as clinically significant pathogens or contaminants using predefined criteria based on organism identity, the pattern of positive bottles and sets, and available clinical information. The primary analysis will compare participant-level pathogen detection between the initial four-bottle strategy and the complete six-bottle strategy using paired methods.
The study is intended to quantify the diagnostic performance of a simplified collection strategy and the incremental value of the additional blood culture set. The results may inform local blood culture collection policy and future diagnostic stewardship recommendations.
- Conditions
- Bacteremia and Sepsis, Bloodstream Infection
- Being tested
- Standardized sequential blood culture collection
- Keywords
- Blood culture, blood culture collection, venipuncture, diagnostic performance, bloodstream infection, diagnostic stewardship, bacteremia, sepsis, contamination
- Medical subject headings
- Bacteremia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized sequential blood culture collectionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Standardized sequential blood culture collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Proportion of participants in whom a clinically significant bloodstream pathogen is detected only in the additional two-bottle set and is not detected in the initial four bottles.
Measured: From initial collection through completion of the five-day blood culture incubation period
Blood culture contamination
Participant-level occurrence of one or more isolates classified as contaminants in the initial four-bottle strategy and in the complete six-bottle strategy, according to predefined microbiological and clinical criteria.
Measured: From initial collection through completion of the five-day blood culture incubation period
Overall blood culture positivity
Participant-level detection of any microorganism, including clinically significant pathogens and contaminants, using the initial four bottles and using all six bottles.
Measured: From initial collection through completion of the five-day blood culture incubation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteremia and SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izola General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Primorska
- Responsible party
- Principal investigator, Samo Jeverica, Izola General Hospital
- Investigators
- Mladen Gasparini, Study director, Izola General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751575
- Sponsor's protocol ID
- 0120-649/2025-2711-6
- Acronym
- SIMPLE-BC
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07751575
- Acronym / sponsor ID
- SIMPLE-BC / 0120-649/2025-2711-6
- Conditions
- Bacteremia and Sepsis, Bloodstream Infection
- Keywords
- Blood culture, blood culture collection, venipuncture, diagnostic performance, bloodstream infection, diagnostic stewardship, bacteremia, sepsis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Izola General HospitalUniversity, hospital or other
- Collaborators
- University of Primorska
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
All bottles will be transported, incubated for five days, and processed according to routine microbiology laboratory procedures. Positive cultures will undergo microorganism identification and antimicrobial susceptibility testing when clinically indicated. Isolates will be classified as clinically significant pathogens or contaminants using predefined criteria based on organism identity, the pattern of positive bottles and sets, and available clinical information. The primary analysis will compare participant-level pathogen detection between the initial four-bottle strategy and the complete six-bottle strategy using paired methods.
The study is intended to quantify the diagnostic performance of a simplified collection strategy and the incremental value of the additional blood culture set. The results may inform local blood culture collection policy and future diagnostic stewardship recommendations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standardized Six-Bottle Blood Culture Collection | Experimental | Diagnostic Test: Standardized sequential blood culture collectionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized sequential blood culture collectionTwo 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. | Diagnostic test | Standardized Six-Bottle Blood Culture Collection |
Primary outcome
Paired difference in detection of clinically significant bloodstream pathogens
Time frame: 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.
3 secondary outcomes
Incremental diagnostic yield of the additional blood culture set
Time frame: From initial collection through completion of the five-day blood culture incubation period
Blood culture contamination
Time frame: From initial collection through completion of the five-day blood culture incubation period
Overall blood culture positivity
Time frame: From initial collection through completion of the five-day blood culture incubation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mladen Gasparini study director
Izola General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized sequential blood culture collection in people with Bacteremia and Sepsis and Bloodstream Infection, run by Izola General Hospital at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired difference in detection of clinically significant bloodstream pathogens (time frame: From initial collection through completion of the five-day blood culture incubation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.