NCT05722119

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 22, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

February 1, 2023

Last Update Submit

February 20, 2023

Conditions

Kidney Transplant; ComplicationsDiarrhoea;AcuteDiarrhea Infectious

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (10)

  • Difference in the proportion of patients with an adaptation of immunosuppressive therapy

    30 days

  • Difference in the time to adaptation of immunosuppressive therapy

    30 days

  • Proportion of patients with additional tests for the etiological diagnosis of diarrhea

    30 days

  • Number of additional tests for the etiological diagnosis of diarrhea

    30 days

  • Time to digestive endoscopy

    30 days

  • +5 more secondary outcomes

Study Arms (3)

Multiplex test

EXPERIMENTAL

Multiplex Polymerase Chain Reaction (PCR) assay on stool samples, within 2 hours, in patients with acute diarrhea

Diagnostic Test: FilmArray GI

Standard of care tests

NO INTERVENTION

Coproculture with direct examination and Clostridium difficile and A-B toxins search, parasitological examination of the stool and search for enteric viruses (rotavirus, adenovirus, norovirus, astrovirus) in patients with acute diarrhea

Control group without diarrhea

EXPERIMENTAL

Multiplex Polymerase Chain Reaction (PCR) assay on stool samples in asymptomatic patients

Diagnostic Test: FilmArray GI

Interventions

FilmArray GIDIAGNOSTIC_TEST

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

Also known as: Multiplex Polymerase Chain Reaction (PCR) assay
Control group without diarrheaMultiplex test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who received an identical HLA transplant from a related donor
  • Patients without health insurance
  • Patients under guardianship or curatorship
  • Pregnant (or breastfeeding) patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysentery

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Jérôme Le Goff, MD PhD

CONTACT

+33142499493jerome.legoff@aphp.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

February 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

February 22, 2023

Record last verified: 2023-01