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NCT05722119
GastroIntestinal Panel in Kidney Transplant Patients
Conditions: Kidney Transplant; Complications, Diarrhoea;Acute, Diarrhea Infectious
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 135
Sponsor: Assistance Publique - Hôpitaux de Paris
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.We propose to conduct a prospective study evaluating 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 yearsInformed consentPatient who received a kidney transplant at least 3 months agoAcute 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 lawExclusion Criteria:Patients who received an identical HLA transplant from a related donorPatients without health insurancePatients under guardianship or curatorshipPregnant (or breastfeeding) patient
Source: ClinicalTrials.gov (NCT05722119). StuddyBuddy aggregates publicly available trial information.