Film Array Pneumonia Plus Panel® Multiplex PCR for Early Adaptation of Antibiotic Prophylaxis During Lung Transplantation (FilmArray-TP)
Film Array Pneumonia Plus Panel® Multiplex PCR for Early Adaptation of Antibiotic Prophylaxis During Lung Transplantation: a Randomized Controlled Trial
Postoperative pneumonia significantly worsens the prognosis for patients undergoing lung transplantation (LT). It is therefore recommended to use antibiotic prophylaxis after LT, although the specific types of antibiotics or the duration of treatment are not specified. International practices vary (3), with the recipient's colonization status being the primary factor influencing the choice and duration of antibiotic prophylaxis. This prophylaxis is sometimes decided upon several months before LT, raising questions about its appropriateness at the time of surgery. It is subsequently adjusted based on pre- and postoperative bacterial documentations, particularly those from the donor. However, results of usual bacteriological samples are not available until 3 to 5 days after the transplant. Therefore, there is a risk of inappropriate antibiotic prophylaxis, which could lead to complications, such as severe infections. Film Array Pneumonia Plus Panel® (FAPP®, Biomérieux) is a rapid microbiological technique which has been evaluated in the diagnosis of pneumonia, yielding very good performances. This tool is able to diagnose a panel of several bacteria in the respiratory tract with results available 4 hours after sampling. However, it has never been evaluated to adapt antibiotic prophylaxis during lung transplantation.
Investigators hypothesize here that the use of FAPP in addition to usual bacterial cultures among donor and recipient samples could help to adapt faster antibiotic prophylaxis, limit the time spent with inappropriate antibiotic treatment and therefore reduce infectious complications after LT.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male or female patient, aged 18 years or over,
- Patients who have given their written informed consent to participate in the study,
- Patients registered on the lung transplant list,
- Patients who are a beneficiary or entitled to a social security scheme
Exclusion Criteria:
- Patient for whom a combined transplant (i.e. combining lung transplantation with another organ transplant) is planned,
- Patient in a period of exclusion from another research protocol at the time of signing consent,
- Patients covered by Articles L1121-5 to 1121-8 of the Public Health Code (minor patient, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：FAPP + bacterial culture"
Patients with FAPP+
|
Antibiotic prophylaxis will be adapted according to the results of the FAPP performed on donor and recipient respiratory samples.
In case of negative results, antibiotics will not be stopped based on these results only.
In the standard of care arm, antibiotics will not be modified until the results of bacterial cultures are available
|
|
无干预：bacterial culture alone = standard of care
Patients without FAPP+
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration (hours) of inadequate antibiotic prophylaxis following lung transplantation.
大体时间：At the time of antibiotic modification or cessation
|
Inadequate antibiotic prophylaxis is defined as prophylaxis whose spectrum does not cover the bacteria present in bacteriological samples and deemed to be pathogenic. The duration of inadequate antibiotic prophylaxis is defined as the time spent between the start of probabilistic antibiotic prophylaxis and the start of a second course of antibiotic prophylaxis prescribed by the clinician to broaden the spectrum due to uncovered bacteria. |
At the time of antibiotic modification or cessation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time (in hours) taken to report the results of FAPP® tests and bacterial cultures on the donor's and the recipient's respiratory samples
大体时间：From the sample to the availability of results
|
Adequation between FAPP and bacterial microbiology: number and type of bacteria identified in both samples
|
From the sample to the availability of results
|
|
Microbiological agreement between FAPP® results and those from standard cultures:
大体时间：From the introduction of antibiotics to antibiotics modification based on FAPP results
|
Number of patients for whom FAPP induced a change in antibiotic prophylaxis reported to the total number of patients in the intervention group
|
From the introduction of antibiotics to antibiotics modification based on FAPP results
|
|
Proportion of patients for whom FAPP® led to a change in antibiotic prophylaxis
大体时间：Day 90
|
Number of paients for whom a diagnosis of VAP was made reported to the total number of patients
|
Day 90
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RCAPHM25_0392
- ID RCB: 2025-A02327-42 (其他标识符：ANSM)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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