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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
|
No Intervention: bacterial culture alone = standard of care
Patients without FAPP+
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration (hours) of inadequate antibiotic prophylaxis following lung transplantation.
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time (in hours) taken to report the results of FAPP® tests and bacterial cultures on the donor's and the recipient's respiratory samples
Time Frame: 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:
Time Frame: 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
Time Frame: Day 90
|
Number of paients for whom a diagnosis of VAP was made reported to the total number of patients
|
Day 90
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RCAPHM25_0392
- ID RCB: 2025-A02327-42 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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