A Phase 3 interventional study of FilmArray GI in Kidney Transplant; Complications, Diarrhoea;Acute and Diarrhea Infectious, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Diagnostic
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).
44 studies on the registry are indexed under Dysentery; 6 are open to participants now.
This study's planned enrollment of 135 is below the median of 163 across 38 interventional studies indexed under Dysentery.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multiplex Polymerase Chain Reaction (PCR) assay on stool samples, within 2 hours, in patients with acute diarrhea
Diagnostic Test: FilmArray GI
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
Multiplex Polymerase Chain Reaction (PCR) assay on stool samples in asymptomatic patients
Diagnostic Test: FilmArray GI
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
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)
Time frame: 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)
Time frame: 1 week
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)
Time frame: 30 days
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)
Time frame: 30 days
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)
Time frame: 30 days
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)
Time frame: 30 days
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)
Time frame: 30 days
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)
Time frame: 30 days
Proportion of patients with asymptomatic carriage of infectious agents
Proportion of patients with asymptomatic carriage of infectious agents in the asymptomatic control group
Time frame: Day 1
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
Time frame: Day 1
Alpha-diversity
Microbiota alpha-diversity on a stool sample at baseline
Time frame: Day 1
Beta-diversity
Microbiota beta-diversity on a stool sample at baseline
Time frame: Day 1
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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