GastroIntestinal Panel in Kidney Transplant Patients (GIPIK)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Transplant; Complications; Diarrhoea;Acute; Diarrhea Infectious
• Intervention / Treatment: Diagnostic test: FilmArray GI

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiplex test; Multiplex Polymerase Chain Reaction (PCR) assay on stool samples, within 2 hours, in patients with acute diarrhea	Diagnostic test: FilmArray GI; Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel; Other Names: Multiplex Polymerase Chain Reaction (PCR) assay
No Intervention: Standard of care tests; 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; Multiplex Polymerase Chain Reaction (PCR) assay on stool samples in asymptomatic patients	Diagnostic test: FilmArray GI; Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel; 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Diarrhea; Dysentery
• Other Study ID Numbers: APHP211588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No