Clinical trial NCT05722184: Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa
Official title: Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacterial Infections
Keywords: blood culture
diagnostics
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Reactivos para Diagnóstico, S.L.
name: University Ghent
name: Université Libre de Bruxelles
name: Commissariat A L'energie Atomique
name: Centre Hospitalier Universitaire Yalgado Ouédraogo
name: Centre National Hospitalier et Universitaire de Pneumo-Phtisiologie de Cotonou
name: European and Developing Countries Clinical Trials Partnership (EDCTP)
First posted: 2023-02-10
Enrollment: 1347
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time-to-actionable result
timeFrame: Within 8 days
Secondary outcomes:
measure: Time-to-detection
timeFrame: Within 8 days
measure: Yield
timeFrame: 2 years
measure: Diagnostic performance
timeFrame: 2 years
Other outcomes:
measure: Yield - Antibiotic use
timeFrame: 2 years
measure: Yield - V blood sampled
timeFrame: 2 years
Locations:
city: Boko
country: Benin
facility: Hôpital Saint Jean de Dieu de Boko
city: Cotonou
country: Benin
facility: Centre National Hospitalier et Universitaire Hubert Koutoukou MAGA
Study officials:
affiliation: Instituut voor Tropische Geneeskunde
name: Barbara Barbé
role: PRINCIPAL_INVESTIGATOR
References: