Clinical trial NCT05722119: GastroIntestinal Panel in Kidney Transplant Patients
Official title: Clinical Impact of the BioFire gastroIntestinal Panel for the Management of Diarrhea in Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Kidney Transplant; Complications
Diarrhoea;Acute
Diarrhea Infectious
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: Difference in the proportion of patients with anti-infectious treatment change
timeFrame: 1 week
measure: Difference in the time to anti-infectious treatment change
timeFrame: 1 week
Secondary outcomes:
measure: Difference in the proportion of patients with an adaptation of immunosuppressive therapy
timeFrame: 30 days
measure: Difference in the time to adaptation of immunosuppressive therapy
timeFrame: 30 days
measure: Proportion of patients with additional tests for the etiological diagnosis of diarrhea
timeFrame: 30 days
measure: Number of additional tests for the etiological diagnosis of diarrhea
timeFrame: 30 days
measure: Time to digestive endoscopy
timeFrame: 30 days
measure: Duration of diarrhea
timeFrame: 30 days
measure: Proportion of patients with asymptomatic carriage of infectious agents
timeFrame: Day 1
measure: Quantitative polymerase chain reaction (PCR) by multiplex PCR for infectious agents
timeFrame: Day 1
measure: Alpha-diversity
timeFrame: Day 1
measure: Beta-diversity
timeFrame: Day 1
Other outcomes:
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