Diarrhea Infectious, Diarrhoea;Acute, Kidney Transplant; Complications
Conditions
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).
Interventions
DIAGNOSTIC_TESTFilmArray GI
Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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 |
| Alpha-diversity | Day 1 | Microbiota alpha-diversity on a stool sample at baseline |
| Beta-diversity | Day 1 | Microbiota beta-diversity on a stool sample at baseline |
| 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 |
| 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) |
Contacts
Primary ContactJérôme Le Goff, MD PhD
Outcome results
None listed