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

NCT07792018 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Lung Transplantation

Interventions

DIAGNOSTIC_TEST

Early adapation of antibiotic prophylaxis according to FAPP results.

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

Sponsors & Collaborators

  • Marie Lannelongue Hospital, Le Plessis Robinson, France

    collaborator UNKNOWN
  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2029-11-30
Completion
2030-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792018 on ClinicalTrials.gov