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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05722119
Other study ID # APHP211588
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date February 2023
Est. completion date September 2024

Study information

Verified date January 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Jérôme Le Goff, MD PhD
Phone +33142499493
Email jerome.legoff@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 135
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
FilmArray GI
Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

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