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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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
|
|
介入なし：bacterial culture alone = standard of care
Patients without FAPP+
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Duration (hours) of inadequate antibiotic prophylaxis following lung transplantation.
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time (in hours) taken to report the results of FAPP® tests and bacterial cultures on the donor's and the recipient's respiratory samples
時間枠：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:
時間枠：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
時間枠：Day 90
|
Number of paients for whom a diagnosis of VAP was made reported to the total number of patients
|
Day 90
|
協力者と研究者
協力者
協力者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- RCAPHM25_0392
- ID RCB: 2025-A02327-42 (その他の識別子：ANSM)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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