GastroIntestinal Panel in Kidney Transplant Patients

Phase 3

Not yet recruiting

• Conditions: Diarrhoea;Acute; Kidney Transplant; Complications; Diarrhea Infectious
• Interventions: Diagnostic Test: FilmArray GI

• Registration Number: NCT05722119
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-02
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-10
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-22
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 135

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group without diarrhea	FilmArray GI	Multiplex Polymerase Chain Reaction (PCR) assay on stool samples in asymptomatic patients
Multiplex test	FilmArray GI	Multiplex Polymerase Chain Reaction (PCR) assay on stool samples, within 2 hours, in patients with acute diarrhea

Primary Outcome Measures

Name	Time	Method
Difference in the proportion of patients with anti-infectious treatment change	1 week	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)
Difference in the time to anti-infectious treatment change	1 week	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)

Secondary Outcome Measures

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