Clinical diagnostic trial in Western Africa of a simplified blood culture system to improve healthcare in low-resource settings

Project Details

Description

Bloodstream infections (BSI) are an important cause of disease and death worldwide, aggravated by increasing
antimicrobial resistance which affects mainly low-resource settings (LRS). Diagnosis of 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 (that are being use in high income countries), manual
blood culture 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 (ITM), in collaboration with Ghent
University (Belgium) 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 bacteria organisms, improving patient’s diagnosis and more directed antibiotic treatment. The
lensfree microscope is an additional module for the Bactinsight blood culture system.
In the SIMBLE trial, we will evaluate the Bactinsight blood culture system 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, we will evaluate the ease-of-use, acceptability, adoptability and
performance of Bactinsight blood culture system 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.
AcronymSIMBLE
StatusActive
Effective start/end date1/07/2131/12/24

Funding

  • European & Developing Countries Clinical Trials Partnership : €4,564,621.25