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Transplantation InfectionSTENO_SOTNCT05193058

Description of Lung Transplant Patients With Microbiologically Documented Stenotrophomonas Maltophilia Pneumonia and Impact of Treatment on Outcome

An observational study of Transplantation Infection, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Stenotrophomonas maltophilia is a multi-resistant Gram-negative bacillus and is an opportunistic pathogen. Stenotrophomonas maltophilia infections are associated with a significant morbidity and mortality, particularly in immunocompromised patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transplantation Infection
How many people
70 participants
Where
1 siteFrance
Study dates
22 Nov 2021to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Patients managed for Stenotrophomonas maltophilia pneumonia following a lung or heart-lung transplant between 01/01/2011 and 01/01/2021

Who may be able to join

  • Patient whose age ≥ 18 years
  • Patient who has received a lung (mono or bi-pulmonary) or heart-lung transplant
  • Patient with documented pneumopathy (clinico-radiological definition) (positive respiratory specimen for Stenotrophomonas maltophilia)
  • French speaking patient

Who cannot join

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his data for this research

Trial locations and contacts

1 site in 1 country.

Benoit PILMIS, MD contact

144127820 ext. +33

bpilmis@ghpsj.fr

Helene BEAUSSIER contact

0144127883 ext. +33

crc@ghpsj.fr

France1 site, 1 recruiting

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

    Benoit PILMIS, MD

    Recruiting

Other trials in France

About this study

Stenotrophomonas maltophilia is a multi-resistant Gram-negative bacillus and is an opportunistic pathogen. Stenotrophomonas maltophilia infections are associated with a significant morbidity and mortality, particularly in immunocompromised patients. The mortality of infections (bacteremia, pneumonia) related to Stenotrophomonas maltophilia is variable and is estimated between 21 and 69%. Stenotrophomonas maltophilia pneumopathies have been mainly described in patients hospitalized in intensive care and benefiting from mechanical ventilation. The existence of immunosuppression seems to be a risk factor for the transition from Stenotrophomonas maltophilia pulmonary colonization to Stenotrophomonas maltophilia pulmonary infection. The reference treatment for Stenotrophomonas maltophilia-associated pneumonia is the combination of trimethoprim and sulfamthoxazole, a molecule that lung transplant patients routinely receive as a preventive treatment for Pneumocysitis jirovecii infection. There is no consensus on the value of routine dual-antibiotic therapy, and it varies from one center to another and from one country to another.

The main objective is to compare the clinical-microbiological evolution of lung transplant patients treated for Stenotrophomonas maltophilia pneumopathy according to the prescription of a mono- or bi-antibiotherapy.

The secondary objective is to evaluate the resistance rate of Stenotrophomonas maltophilia strains isolated from respiratory samples according to the anti-pneumocystis prophylactic molecule received by the patient.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical-microbiological course of lung transplant patients treated for Stenotrophomonas maltophilia pneumonia

    This outcome corresponds to the comparison of mortality and recurrence rates of Stenotrophomonas maltophilia pneumonia according to the prescription of mono- or dual-antibiotic therapy.

    Measured: Day 1

Secondary outcomes (1)

  1. Resistance rate of Stenotrophomonas maltophilia strains

    This outcome corresponds to the Trimethorpime/sulfamethoxazole resistance rate of Stenotrophomonas maltophilia strains.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2022
  2. Study start22 Nov 2021
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05193058
Sponsor's protocol ID
STENO_SOT
Acronym
STENO_SOT
Status last verified
Apr 2023
First submitted
31 Dec 2021
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Denton M, Kerr KG. Microbiological and clinical aspects of infection associated with Stenotrophomonas maltophilia. Clin Microbiol Rev. 1998 Jan;11(1):57-80. doi: 10.1128/CMR.11.1.57.

    PubMed 9457429

  • Senol E, DesJardin J, Stark PC, Barefoot L, Snydman DR. Attributable mortality of Stenotrophomonas maltophilia bacteremia. Clin Infect Dis. 2002 Jun 15;34(12):1653-6. doi: 10.1086/340707. Epub 2002 May 24.

    PubMed 12032905

  • Prates M, Fernandes F, Proenca F, Mussa Y, Tavares A, Pereira A. Oral Infection Caused by Stenotrophomonas maltophilia: A Rare Presentation of an Emerging Opportunistic Pathogen. Case Rep Infect Dis. 2020 Jan 29;2020:6346120. doi: 10.1155/2020/6346120. eCollection 2020.

    PubMed 32082659

  • Hashimoto T, Komiya K, Fujita N, Usagawa Y, Yamasue M, Umeki K, Ando M, Nureki SI, Hiramatsu K, Kadota JI. Risk factors for 30-day mortality among patients with Stenotrophomonas maltophilia bacteraemia. Infect Dis (Lond). 2020 Jun;52(6):440-442. doi: 10.1080/23744235.2020.1734653. Epub 2020 Mar 3. No abstract available.

    PubMed 32122208

  • Saugel B, Eschermann K, Hoffmann R, Hapfelmeier A, Schultheiss C, Phillip V, Eyer F, Laugwitz KL, Schmid RM, Huber W. Stenotrophomonas maltophilia in the respiratory tract of medical intensive care unit patients. Eur J Clin Microbiol Infect Dis. 2012 Jul;31(7):1419-28. doi: 10.1007/s10096-011-1459-8. Epub 2011 Nov 7.

    PubMed 22057419

  • Flamm RK, Shortridge D, Castanheira M, Sader HS, Pfaller MA. In Vitro Activity of Minocycline against U.S. Isolates of Acinetobacter baumannii-Acinetobacter calcoaceticus Species Complex, Stenotrophomonas maltophilia, and Burkholderia cepacia Complex: Results from the SENTRY Antimicrobial Surveillance Program, 2014 to 2018. Antimicrob Agents Chemother. 2019 Oct 22;63(11):e01154-19. doi: 10.1128/AAC.01154-19. Print 2019 Nov.

    PubMed 31427295

  • Chang YT, Lin CY, Chen YH, Hsueh PR. Update on infections caused by Stenotrophomonas maltophilia with particular attention to resistance mechanisms and therapeutic options. Front Microbiol. 2015 Sep 2;6:893. doi: 10.3389/fmicb.2015.00893. eCollection 2015.

    PubMed 26388847

Questions about this trial

What is this clinical trial studying?

An observational study of Transplantation Infection, run by Fondation Hôpital Saint-Joseph at 1 site in France.

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 4 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Benoit PILMIS, MD (144127820 ext. +33, bpilmis@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical-microbiological course of lung transplant patients treated for Stenotrophomonas maltophilia pneumonia (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05193058, which also lists 7 linked publications.

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 27 Apr 2023.

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