Clinical Impact of the BioFire gastroIntestinal Panel for the Management of Diarrhea in Kidney Transplant Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 135
- 主要终点
- Difference in the proportion of patients with anti-infectious treatment change
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who received an identical HLA transplant from a related donor
- •Patients without health insurance
- •Patients under guardianship or curatorship
- •Pregnant (or breastfeeding) patient
结局指标
主要结局
Difference in the proportion of patients with anti-infectious treatment change
时间窗: 1 week
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)
Difference in the time to anti-infectious treatment change
时间窗: 1 week
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)
次要结局
- Proportion of patients with asymptomatic carriage of infectious agents(Day 1)
- Quantitative polymerase chain reaction (PCR) by multiplex PCR for infectious agents(Day 1)
- 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)
- Alpha-diversity(Day 1)
- Duration of diarrhea(30 days)
- Beta-diversity(Day 1)