Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa - Trial NCT05722184

Timeline & Enrollment

Primary Outcome

Time-to-actionable result

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.

ICD-10 Classifications