combacte-net News Item

LAB-Net prepared sites for VALUE-Dx trials

COMBACTE's LAB-Net team is highly involved in VALUE-Dx' PRUDENCE and ADEQUATE clinical trials. On 17 and 18 September 2021, an online Network Training meeting has officially kicked off PRUDENCE, a clinical trial aiming to assess effectiveness of Community acquired acute respiratory tract infection (CA-ARTI) diagnostics in terms of both reductions in antimicrobial prescribing, and patient recovery. Site training is also one of the current priorities of LAB-Net in the ADEQUATE-Paediatric trial.

On 17 and 18 September 2021, an online Network Training meeting has officially kicked off PRUDENCE, a clinical trial aiming to assess effectiveness of CA-ARTI diagnostics in terms of both reductions in antimicrobial prescribing, and patient recovery. During the Network Training meeting, the sites were trained by the study team on all the aspects of the trial, from patient recruitment to performance of the diagnostic test and completion of the eCRF. Specifically, the LAB-Net team has trained the long term care facilities (LTCF) on sample collection and management for the Microbiology-Biomarker study embedded in PRUDENCE. After almost a year’s delay due to the COVID-19 pandemic, this online session represents finally the start of PRUDENCE.

ADEQUATE-Paediatric aims to assess the impact of rapid syndromic diagnostic testing in patients with ARTI at the emergency department. As of 1 October 2021, nine patients were enrolled in ADEQUATE-Paediatric and four of the six sites were trained by the study team during virtual site initiation visits (SIVs). The active sites are situated in Germany, Switzerland, Greece, and Spain. During these SIVs, LAB-Net is responsible for providing instruction on all aspects related to sampling and management. In addition, LAB-Net provided sites with initial supplies and a Sample Collection and Management manual.

 

ABOUT ADEQUATE-Paediatric and PRUDENCE

ADEQUATE-Paediatric and PRUDENCE are studies within the VALUE-Dx consortium. VALUE-Dx is an Innovative Medicines Initiative project initiated by six in vitro diagnostic companies who joined forces with 20 non-industry partners to combat antimicrobial resistance and improve patient outcomes.

LAB-Net as Central Laboratory for PRUDENCE 1

ADEQUATE-Paediatric (Advanced Diagnostics for Enhanced QUality of Antibiotic prescription in respiratory Tract infections in Emergency rooms – Paediatric) aims to assess the impact of rapid syndromic diagnostic testing in patients with Acute Respiratory Tract Infections at the emergency department on  hospital admission rates, antimicrobial prescriptions (days of treatment) and the non-inferiority in terms of clinical outcome.

PRUDENCE (Platform Randomised controlled trial of point of care Diagnostics for Enhancing the quality of aNtibiotic prescribing for Community acquired acute respiratory tract infection in ambulatory care in Europe) aims to determine if having a CA-ARTI diagnostic (CA-ARTI-Dx) test result available when a clinician is considering, or plans to prescribe an antimicrobial, leads to more appropriate prescribing decisions, without causing harm to patients.

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