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NCT Number: NCT07792018

Film Array Pneumonia Plus Panel® Multiplex PCR for Early Adaptation of Antibiotic Prophylaxis During Lung Transplantation

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.

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Key information

Conditions

Lung Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Early adapation of antibiotic prophylaxis according to FAPP results.

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Collaborators

  • Marie Lannelongue Hospital, Le Plessis Robinson, France

Registry information

Official study title

Film Array Pneumonia Plus Panel® Multiplex PCR for Early Adaptation of Antibiotic Prophylaxis During Lung Transplantation: a Randomized Controlled Trial

Acronym: FilmArray-TP

Important dates

Study start
2027
Primary completion
2029
Study completion
2030
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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