Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa

Bacterial Infections Clinical Trial

— SIMBLE-FIELD  

Official title:

Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722184
• Other study ID #: SIMBLE-FIELD
• Status: Recruiting
• Start date: June 8, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Institute of Tropical Medicine, Belgium
• Contact: Liselotte Hardy, Dr.
• Phone: +32(0)32476693
• Email: lhardy[@]itg.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1347
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

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.

Locations

Country	Name	City	State
Benin	Hôpital Saint Jean de Dieu de Boko	Boko
Benin	Centre National Hospitalier et Universitaire Hubert Koutoukou MAGA	Cotonou

Sponsors (8)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Centre Hospitalier Universitaire Yalgado Ouédraogo, Centre National Hospitalier et Universitaire de Pneumo-Phtisiologie de Cotonou, Commissariat A L'energie Atomique, European and Developing Countries Clinical Trials Partnership (EDCTP), Reactivos para Diagnóstico, S.L., Université Libre de Bruxelles, University Ghent

Country where clinical trial is conducted

Benin, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	2 years
Other	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).	2 years
Primary	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.	Within 8 days
Secondary	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.	Within 8 days
Secondary	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.	2 years
Secondary	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.	2 years