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

NCT05722184 | Completed

• 1 other identifier: SIMBLE-FIELD
• Study Type: observational
• Target: 1,724
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bacterial Infections

Keywords

blood culture; diagnostics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time-to-detection

  Within 8 days

• Yield

  2 years

• Diagnostic performance

  2 years

Other Outcomes (2)

• Yield - Antibiotic use

  2 years

• Yield - V blood sampled

  2 years

Study Arms (3)

CNHU-HKM

BactInsight system compared to BacT/ALERT® 3D

Diagnostic Test: BactInsight blood culture system

Hôpital Saint Jean de Dieu, Boko

BactInsight system compared to manual blood culture system (visual inspection)

Diagnostic Test: BactInsight blood culture system

Centre Hospitalier Universitaire Yalgado Ouédraogo

BactInsight system compared to BacTec FX40

Diagnostic Test: BactInsight blood culture system

Interventions

BactInsight blood culture system DIAGNOSTIC_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.

CNHU-HKM; Centre Hospitalier Universitaire Yalgado Ouédraogo; Hôpital Saint Jean de Dieu, Boko

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

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

Study Sites (2)

Hôpital Saint Jean de Dieu de Boko

Boko, Benin

Location

Centre National Hospitalier et Universitaire Hubert Koutoukou MAGA

Cotonou, Benin

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Barbara Barbé

  Instituut voor Tropische Geneeskunde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: June 8, 2023
• Primary Completion: May 8, 2025
• Study Completion: September 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)