Film Array Pneumonia Plus Panel® Multiplex PCR for Early Adaptation of Antibiotic Prophylaxis During Lung Transplantation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 98
- 主要终点
- Duration (hours) of inadequate antibiotic prophylaxis following lung transplantation.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •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
排除标准
- •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).
研究组 & 干预措施
FAPP + bacterial culture"
Patients with FAPP+
干预措施: Early adapation of antibiotic prophylaxis according to FAPP results. (Diagnostic Test)
bacterial culture alone = standard of care
Patients without FAPP+
结局指标
主要结局
Duration (hours) of inadequate antibiotic prophylaxis following lung transplantation.
时间窗: 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.
次要结局
- Time (in hours) taken to report the results of FAPP® tests and bacterial cultures on the donor's and the recipient's respiratory samples(From the sample to the availability of results)
- Microbiological agreement between FAPP® results and those from standard cultures:(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(Day 90)