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

NCT07792018 | Not Yet Recruiting

• 2 other identifiers: RCAPHM25_0392ID RCB: 2025-A02327-42
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Antibiotic prophylaxis; lung transplantation; multiplex PCR; Film Array Pneumonia Plus Panel

Outcome Measures

Primary Outcomes (1)

• Duration (hours) of inadequate antibiotic prophylaxis following lung transplantation.

  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 Outcomes (3)

• Time (in hours) taken to report the results of FAPP® tests and bacterial cultures on the donor's and the recipient's respiratory samples

  From the sample to the availability of results

• Microbiological agreement between FAPP® results and those from standard cultures:

  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

  Day 90

Study Arms (2)

FAPP + bacterial culture"

EXPERIMENTAL

Patients with FAPP+

Diagnostic Test: Early adapation of antibiotic prophylaxis according to FAPP results.

bacterial culture alone = standard of care

NO INTERVENTION

Patients without FAPP+

Interventions

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

FAPP + bacterial culture"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient for whom a combined transplant (i.e. combining lung transplantation with another organ transplant) is planned,
• 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).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead
• Marie Lannelongue Hospital, Le Plessis Robinson, France: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: August 28, 2026

Record last verified: 2026-08