An observational study in Bacterial Infections, sponsored by Institute of Tropical Medicine, Belgium. Completed at 2 sites in Benin. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Institute of Tropical Medicine, Belgium · Observational
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.
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
This study's enrollment of 1,724 is above the median of 200 across 185 observational studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 104 studies on the registry; 21 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BactInsight system compared to BacT/ALERT® 3D
Diagnostic Test: BactInsight blood culture system
BactInsight system compared to manual blood culture system (visual inspection)
Diagnostic Test: BactInsight blood culture system
BactInsight system compared to BacTec FX40
Diagnostic Test: BactInsight blood culture system
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.
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.
Time frame: Within 8 days
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.
Time frame: 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. o 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.
Time frame: 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.
Time frame: 2 years
Yield - Antibiotic use
Test whether yield differs in case of antibiotic use (yes/no) within 48 hours prior to blood culture sampling: Pearson Chi-square test (or Fisher exact test in case of small sample size).
Time frame: 2 years
Yield - V blood sampled
Test whether yield differs with different volumes of blood sampled (e.g. 5-8 ml; 8-10 ml; 10-15 ml): Pearson Chi-square test (or Fisher exact test in case of small sample size).
Time frame: 2 years
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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