Bacterial InfectionsSIMBLE-FIELDNCT05722184
Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa
An observational study of Bacterial Infections, run by Institute of Tropical Medicine, Belgium at 2 sites in Benin.
Trial summary
Diagnosis of bloodstream infections (BSI) is done by sampling blood in blood culture bottles that are checked for growth in the microbiology laboratory. In LRS, microbiology laboratories are however scarce, and BSI cannot be diagnosed, resulting in overuse of antibiotics which fuels AMR. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- BactInsight blood culture system
- How many people
- 1,724 participants
- Where
- 2 sitesBenin
- Study dates
- 8 Jun 2023to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients older then 15 years old presenting themselves with indications for blood culture sampling and for whom collection of a blood culture sample is part of standard clinical practice.
Who may be able to join
- With indications for blood culture sampling and for whom collection of a blood culture sample is part of standard clinical practice
- Willing and able to provide written informed consent (assent for minors)
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Benin2 sites
Hôpital Saint Jean de Dieu de Boko
Boko
Centre National Hospitalier et Universitaire Hubert Koutoukou MAGA
Cotonou
About this study
Diagnosis of bloodstream infections (BSI) is done by sampling blood in blood culture bottles that are checked for growth in the microbiology laboratory. In LRS, microbiology laboratories are however scarce, and BSI cannot be diagnosed, resulting in overuse of antibiotics which fuels AMR. For diagnosis of BSI, so-called manual blood culture (equipment-free) systems are used in LRS, with daily visual inspection for growth. Compared to automates, manual systems are less sensitive, and growth is slower; in addition, training and experience are needed before laboratory staff is competent to detect growth when inspecting the blood culture bottles.
A simplified blood culture system could enable expanded use of blood cultures in LRS and would thus improve BSI treatment. Ongoing research at the Institute of Tropical Medicine, in collaboration with Ghent University has resulted in a novel, simple, cheap, open-access and robust blood culture system, the Bactinsight blood culture system. This system consists of two modules. Firstly, a portable, battery-operated measurement device (turbidimeter), which monitors and detects bacterial growth in blood culture bottles based on the turbidity of the culture medium caused by bacterial growth. Secondly, optimized blood culture bottles have been developed. A second step in blood cultures is the identification of the causing organism. Researchers at LETI (Grenoble, France) have developed a lensfree microscope, which simplifies and expedites identification of the causative organisms, improving patient's diagnosis and more directed antibiotic treatment. The lensfree microscope is an additional module for the Bactinsight blood culture system.
In SIMBLE, the Bactinsight blood culture system will be evaluated against reference systems in two phases. During the optimization phase in Belgium, the performance of Bactinsight turbidimeter + lensfree microscope will be tested in a reference hospital laboratory. In parallel, an in vitro laboratory evaluation of the Bactinsight blood culture system (turbidimeter + blood culture bottles + lensfree microscope) will be done using spiked blood cultures. In the field-testing phase, the ease-of-use, acceptability, adoptability and performance of Bactinsight blood culture system will be evaluated in three hospitals in Benin and Burkina Faso. The blood culture bottles used for this study will be manufactured in a production facility in Benin, that will be installed at the start of the project.
- Conditions
- Bacterial Infections
- Being tested
- BactInsight blood culture system
- Keywords
- blood culture, diagnostics
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BactInsight blood culture systemDiagnostic test
A battery-operated measurement device (turbidimeter), which monitors and detects bacterial growth in blood culture bottles based on the turbidity of the culture medium caused by bacterial growth, in combination with optimized blood culture bottles.
| Study group | Role | What they receive |
|---|---|---|
| CNHU-HKM | BactInsight system compared to BacT/ALERT® 3D Receives: Diagnostic Test: BactInsight blood culture system | |
| Hôpital Saint Jean de Dieu, Boko | BactInsight system compared to manual blood culture system (visual inspection) Receives: Diagnostic Test: BactInsight blood culture system | |
| Centre Hospitalier Universitaire Yalgado Ouédraogo | BactInsight system compared to BacTec FX40 Receives: Diagnostic Test: BactInsight blood culture system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-actionable result
The paired Wilcoxon signed rank test will be used to compare the location of the distribution of time-to-actionable result measurements between the two groups for those with a positive blood culture result.
- BactInsight versus manual system: Time-to-actionable result is compared between both groups with the Wilcoxon signed rank test at the 5% significance level.
- BactInsight versus automated system: The non-inferiority margin equals 12 hours. Non-inferiority is shown if the upper limit of the two-sided 95% confidence interval for the median of the differences from the Wilcoxon signed rank test is lower than 12h i.e. 12 is excluded from the non-parametric confidence interval.
Measured: Within 8 days
Secondary outcomes (3)
Time-to-detection
The paired Wilcoxon signed rank test will be used to compare the location of the distribution of time-to-detection measurements between the two groups for those with a positive blood culture result.
Measured: Within 8 days
Yield
The McNemar's test will be used to compare the yield between the BactInsight system and the manual reference system at the 5% significance level in order to detect if there is a statistically significant difference between the paired binary data in terms of proportions.
- The difference in yield between the BactInsight system and the automated system will be compared to a non-inferiority margin of 15%. Non-inferiority is shown if the lower limit of the two-sided 95% confidence interval is larger than -0.15 i.e. if -0.15 is excluded from the confidence interval. A non-inferiority margin of 15% was chosen as reasonable based on clinical and practical arguments.
Measured: 2 years
Diagnostic performance
Sensitivity and specificity will be calculated for the BactInsight system compared to the composite reference standard, based on the combined result from the components tests i.e. the BactInsight and reference system in use.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start8 Jun 2023
- Primary completion8 May 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,724 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Reactivos para Diagnóstico, S.L., University Ghent, Université Libre de Bruxelles, Commissariat A L'energie Atomique, Centre Hospitalier Universitaire Yalgado Ouédraogo, Centre National Hospitalier et Universitaire de Pneumo-Phtisiologie de Cotonou, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Sponsor
- Investigators
- Barbara Barbé, Principal investigator, Instituut voor Tropische Geneeskunde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722184
- Sponsor's protocol ID
- SIMBLE-FIELD
- Acronym
- SIMBLE-FIELD
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2023
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa
- ClinicalTrials.gov ID
- NCT05722184
- Acronym / sponsor ID
- SIMBLE-FIELD / SIMBLE-FIELD
- Conditions
- Bacterial Infections
- Keywords
- blood culture, diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,724 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Reactivos para Diagnóstico, S.L., University Ghent, Université Libre de Bruxelles, Commissariat A L'energie Atomique, Centre Hospitalier Universitaire Yalgado Ouédraogo, Centre National Hospitalier et Universitaire de Pneumo-Phtisiologie de Cotonou, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 10 Feb 2023 (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.
Diagnosis of bloodstream infections (BSI) is done by sampling blood in blood culture bottles that are checked for growth in the microbiology laboratory. In LRS, microbiology laboratories are however scarce, and BSI cannot be diagnosed, resulting in overuse of antibiotics which fuels AMR. For diagnosis of BSI, so-called manual blood culture (equipment-free) systems are used in LRS, with daily visual inspection for growth. Compared to automates, manual systems are less sensitive, and growth is slower; in addition, training and experience are needed before laboratory staff is competent to detect growth when inspecting the blood culture bottles.
A simplified blood culture system could enable expanded use of blood cultures in LRS and would thus improve BSI treatment. Ongoing research at the Institute of Tropical Medicine, in collaboration with Ghent University has resulted in a novel, simple, cheap, open-access and robust blood culture system, the Bactinsight blood culture system. This system consists of two modules. Firstly, a portable, battery-operated measurement device (turbidimeter), which monitors and detects bacterial growth in blood culture bottles based on the turbidity of the culture medium caused by bacterial growth. Secondly, optimized blood culture bottles have been developed. A second step in blood cultures is the identification of the causing organism. Researchers at LETI (Grenoble, France) have developed a lensfree microscope, which simplifies and expedites identification of the causative organisms, improving patient's diagnosis and more directed antibiotic treatment. The lensfree microscope is an additional module for the Bactinsight blood culture system.
In SIMBLE, the Bactinsight blood culture system will be evaluated against reference systems in two phases. During the optimization phase in Belgium, the performance of Bactinsight turbidimeter + lensfree microscope will be tested in a reference hospital laboratory. In parallel, an in vitro laboratory evaluation of the Bactinsight blood culture system (turbidimeter + blood culture bottles + lensfree microscope) will be done using spiked blood cultures. In the field-testing phase, the ease-of-use, acceptability, adoptability and performance of Bactinsight blood culture system will be evaluated in three hospitals in Benin and Burkina Faso. The blood culture bottles used for this study will be manufactured in a production facility in Benin, that will be installed at the start of the project.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CNHU-HKM | – | Diagnostic Test: BactInsight blood culture systemBactInsight system compared to BacT/ALERT® 3D |
| Hôpital Saint Jean de Dieu, Boko | – | Diagnostic Test: BactInsight blood culture systemBactInsight system compared to manual blood culture system (visual inspection) |
| Centre Hospitalier Universitaire Yalgado Ouédraogo | – | Diagnostic Test: BactInsight blood culture systemBactInsight system compared to BacTec FX40 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients older then 15 years old presenting themselves with indications for blood culture sampling and for whom collection of a blood culture sample is part of standard clinical practice.
Key inclusion criteria (2 listed)
- With indications for blood culture sampling and for whom collection of a blood culture sample is part of standard clinical practice
- Willing and able to provide written informed consent (assent for minors)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| BactInsight blood culture systemA battery-operated measurement device (turbidimeter), which monitors and detects bacterial growth in blood culture bottles based on the turbidity of the culture medium caused by bacterial growth, in combination with optimized blood culture bottles. | Diagnostic test | CNHU-HKM, Centre Hospitalier Universitaire Yalgado Ouédraogo, Hôpital Saint Jean de Dieu, Boko |
Primary outcome
Time-to-actionable result
Time frame: Within 8 days
The paired Wilcoxon signed rank test will be used to compare the location of the distribution of time-to-actionable result measurements between the two groups for those with a positive blood culture result. * BactInsight versus manual system: Time-to-actionable result is compared between both groups with the Wilcoxon signed rank test at the 5% significance level. * BactInsight versus automated system: The non-inferiority margin equals 12 hours. Non-inferiority is shown if the upper limit of the two-sided 95% confidence interval for the median of the differences from the Wilcoxon signed rank test is lower than 12h i.e. 12 is excluded from the non-parametric confidence interval.
3 secondary outcomes
Time-to-detection
Time frame: Within 8 days
Yield
Time frame: 2 years
Diagnostic performance
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Bacterial Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
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.
Barbara Barbé principal investigator
Instituut voor Tropische Geneeskunde
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by Institute of Tropical Medicine, Belgium at 2 sites in Benin.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Benin. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time-to-actionable result (time frame: Within 8 days). 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 9 Dec 2025.