GastroIntestinal Panel in Kidney Transplant Patients

Kidney Transplant; Complications Clinical Trial

— GIPIK  

Official title:

Clinical Impact of the BioFire gastroIntestinal Panel for the Management of Diarrhea in Kidney Transplant Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05722119
• Other study ID #: APHP211588
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea Infectious
• Diarrhoea;Acute
• Dysentery
• Kidney Transplant; Complications

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