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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
|
|
Sin intervención: bacterial culture alone = standard of care
Patients without FAPP+
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Duration (hours) of inadequate antibiotic prophylaxis following lung transplantation.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time (in hours) taken to report the results of FAPP® tests and bacterial cultures on the donor's and the recipient's respiratory samples
Periodo de tiempo: 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:
Periodo de tiempo: 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
Periodo de tiempo: Day 90
|
Number of paients for whom a diagnosis of VAP was made reported to the total number of patients
|
Day 90
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- RCAPHM25_0392
- ID RCB: 2025-A02327-42 (Otro identificador: ANSM)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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