GastroIntestinal Panel in Kidney Transplant Patients

Study Overview
=================
Brief 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).

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

Conditions
-----------------
Kidney Transplant; Complications, Diarrhoea;Acute, Diarrhea Infectious

Intervention / Treatment
-----------------
* Diagnostic Test: FilmArray GI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Informed consent Patient who received a kidney transplant at least 3 months ago Acute diarrhea (at least 3 unformed or liquid stools per day for at least 3 consecutive days or 3 per day and / or weight loss ≥2 kg and / or mucoid and / or bloody stool) or absence of diarrhea for at least a month (asymptomatic non randomized control group) Affiliation to social security in accordance with the recommendations of the French law Exclusion Criteria: Patients who received an identical HLA transplant from a related donor Patients without health insurance Patients under guardianship or curatorship Pregnant (or breastfeeding) patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiplex test<br>Multiplex Polymerase Chain Reaction (PCR) assay on stool samples, within 2 hours, in patients with acute diarrhea | Diagnostic Test: FilmArray GI<br>* Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel<br>* Other names: Multiplex Polymerase Chain Reaction (PCR) assay;|
| No Intervention: Standard of care tests<br>Coproculture with direct examination and Clostridium difficile and A-B toxins search, parasitological examination of the stool and search for enteric viruses (rotavirus, adenovirus, norovirus, astrovirus) in patients with acute diarrhea | |
| Experimental: Control group without diarrhea<br>Multiplex Polymerase Chain Reaction (PCR) assay on stool samples in asymptomatic patients | Diagnostic Test: FilmArray GI<br>* Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel<br>* Other names: Multiplex Polymerase Chain Reaction (PCR) assay;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the proportion of patients with anti-infectious treatment change | Difference in the proportion of patients with an adapation of anti-infectious treatment between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea) | 1 week | 
| Difference in the time to anti-infectious treatment change | Difference in the time to an adaptation of anti-infectious treatment between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the proportion of patients with an adaptation of immunosuppressive therapy | Difference in the proportion of patients with an adaptation of immunosuppressive therapy between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea) | 30 days | 
| Difference in the time to adaptation of immunosuppressive therapy | Difference in the time to adaptation of immunosuppressive therapy between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea) | 30 days | 
| Proportion of patients with additional tests for the etiological diagnosis of diarrhea | Difference in the proportion of patients with additional tests for the etiological diagnosis of diarrhea between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea) | 30 days | 
| Number of additional tests for the etiological diagnosis of diarrhea | Difference in the number additional tests for the etiological diagnosis of diarrhea between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea) | 30 days | 
| Time to digestive endoscopy | Difference in the time to digestive endoscopy between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea) | 30 days | 
| Duration of diarrhea | Difference in the duration of diarrhea between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea) | 30 days | 
| Proportion of patients with asymptomatic carriage of infectious agents | Proportion of patients with asymptomatic carriage of infectious agents in the asymptomatic control group | Day 1 | 
| Quantitative polymerase chain reaction (PCR) by multiplex PCR for infectious agents | Quantitative polymerase chain reaction (PCR) by multiplex PCR for infectious agents on a stool sample at baseline | Day 1 | 
| Alpha-diversity | Microbiota alpha-diversity on a stool sample at baseline | Day 1 | 
| Beta-diversity | Microbiota beta-diversity on a stool sample at baseline | Day 1 |