GastroIntestinal Panel in Kidney Transplant Patients (GIPIK)

Assistance Publique - Hôpitaux de Paris

Status and phase: Not yet enrolling; Phase 3

Conditions: Diarrhoea;Acute; Kidney Transplant; Complications; Diarrhea Infectious

Treatments: Diagnostic Test: FilmArray GI

Study type: Interventional

Funder types: Other

Identifiers

NCT05722119

APHP211588

Details and patient eligibility

About

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).

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 3 patient groups

Multiplex test

Experimental group

Description:

Multiplex Polymerase Chain Reaction (PCR) assay on stool samples, within 2 hours, in patients with acute diarrhea

Treatment:

Diagnostic Test: FilmArray GI

Standard of care tests

No Intervention group

Description:

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

Control group without diarrhea

Experimental group

Description:

Multiplex Polymerase Chain Reaction (PCR) assay on stool samples in asymptomatic patients

Treatment:

Diagnostic Test: FilmArray GI