Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
135 participants
INTERVENTIONAL
2023-02-28
2024-09-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Multiplex test
Multiplex Polymerase Chain Reaction (PCR) assay on stool samples, within 2 hours, in patients with acute diarrhea
FilmArray GI
Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel
Standard of care tests
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
No interventions assigned to this group
Control group without diarrhea
Multiplex Polymerase Chain Reaction (PCR) assay on stool samples in asymptomatic patients
FilmArray GI
Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel
Interventions
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FilmArray GI
Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 without health insurance
* Patients under guardianship or curatorship
* Pregnant (or breastfeeding) patient
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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APHP211588
Identifier Type: -
Identifier Source: org_study_id
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