Bacterial Infections Clinical Trial
Official title:
Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03726216 -
Xydalba Utilization Registry in France
|
||
| Completed |
NCT03605498 -
OR PathTrac (Tracking Intra-operative Bacterial Transmission)
|
||
| Withdrawn |
NCT05269121 -
Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
|
Phase 1/Phase 2 | |
| Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
| Recruiting |
NCT02074865 -
Children's Antibiotic Resistant Infections in Low Income Countries
|
N/A | |
| Completed |
NCT01932034 -
Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software
|
N/A | |
| Completed |
NCT01689207 -
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
|
Phase 1 | |
| Completed |
NCT01412801 -
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
|
Phase 2 | |
| Not yet recruiting |
NCT01159470 -
The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children
|
N/A | |
| Completed |
NCT00983255 -
Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)
|
Phase 1 | |
| Completed |
NCT00799591 -
French Study In ICU Patients Treated With Tigecycline
|
N/A | |
| Completed |
NCT00678106 -
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
|
Phase 1 | |
| Completed |
NCT01074775 -
Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection
|
N/A | |
| Completed |
NCT00478855 -
Tazocin Intervention Study
|
Phase 4 | |
| Terminated |
NCT00431028 -
Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT03634904 -
Serum Ceftazidime Concentrations in Hemodialysis Patients
|
N/A | |
| Recruiting |
NCT05684705 -
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
|
Phase 1 | |
| Recruiting |
NCT03858387 -
PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
|
||
| Enrolling by invitation |
NCT04764058 -
Efficacy and Safety of Colistin Based Antibiotic Therapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06319235 -
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
|
Phase 1/Phase 2 |