Lung TransplantationFilmArray-TPNCT07792018
Film Array Pneumonia Plus Panel® Multiplex PCR for Early Adaptation of Antibiotic Prophylaxis During Lung Transplantation
A study testing Early adapation of antibiotic prophylaxis according to FAPP results. in people with Lung Transplantation, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Early adapation of antibiotic prophylaxis according to FAPP results.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
About this study
Official title: 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.
- Conditions
- Lung Transplantation
- Being tested
- Early adapation of antibiotic prophylaxis according to FAPP results.
- Keywords
- Antibiotic prophylaxis, lung transplantation, multiplex PCR, Film Array Pneumonia Plus Panel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| FAPP + bacterial culture" | Experimental | Patients with FAPP+ Receives: Diagnostic Test: Early adapation of antibiotic prophylaxis according to FAPP results. |
| bacterial culture alone = standard of care | No intervention | Patients without FAPP+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Adequation between FAPP and bacterial microbiology: number and type of bacteria identified in both samples
Measured: From the sample to the availability of results
Microbiological agreement between FAPP® results and those from standard cultures:
Number of patients for whom FAPP induced a change in antibiotic prophylaxis reported to the total number of patients in the intervention group
Measured: 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
Number of paients for whom a diagnosis of VAP was made reported to the total number of patients
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- Marie Lannelongue Hospital, Le Plessis Robinson, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792018
- Sponsor's protocol ID
- RCAPHM25_0392
- Other IDs
- ID RCB: 2025-A02327-42
- Acronym
- FilmArray-TP
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Film Array Pneumonia Plus Panel® Multiplex PCR for Early Adaptation of Antibiotic Prophylaxis During Lung Transplantation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07792018
- Acronym / sponsor ID
- FilmArray-TP / RCAPHM25_0392
- Conditions
- Lung Transplantation
- Keywords
- Antibiotic prophylaxis, lung transplantation, multiplex PCR, Film Array Pneumonia Plus Panel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- Marie Lannelongue Hospital, Le Plessis Robinson, France
- Study start
- Jan 2027 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAPP + bacterial culture" | Experimental | Diagnostic Test: Early adapation of antibiotic prophylaxis according to FAPP results.Patients with FAPP+ |
| bacterial culture alone = standard of care | No intervention | –Patients without FAPP+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | FAPP + bacterial culture" |
Primary outcome
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.
3 secondary outcomes
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
Microbiological agreement between FAPP® results and those from standard cultures:
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early adapation of antibiotic prophylaxis according to FAPP results. in people with Lung Transplantation, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration (hours) of inadequate antibiotic prophylaxis following lung transplantation. (time frame: At the time of antibiotic modification or cessation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.