NCT05722119

GastroIntestinal Panel in Kidney Transplant Patients

Clinical Impact of the BioFire gastroIntestinal Panel for the Management of Diarrhea in Kidney Transplant Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project focuses on the evaluation of the impact of the rapid mutltiplex test on changes in anti-infectious treatments in kidney transplant patients with diarrhea. A higher number of infectious agents detected on the same day of sampling could improve the etiological diagnosis of diarrhea in kidney transplant patients and optimize therapeutic management. A prospective study will be conducted to evaluate the impact of a rapid multiplex test with a wide panel of bacteria, viruses and parasites on the clinical management of kidney transplant patients with acute diarrhea. This impact will be evaluated using a control group of kidney transplant patients with acute diarrhea whose infectious diagnosis will be performed by standard methods. The main objective is to determine the impact of the rapid multiplex test on changes in anti-infectious treatments (initiation, change of molecule, total duration of treatment).

Conditions

• Kidney Transplant; Complications
• Diarrhoea;Acute
• Diarrhea Infectious

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FilmArray GI	Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-02-10
• Last updated: 2023-02-22