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

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Helene BEAUSSIER
  • Phone Number: +33 0144127883
  • Email: crc@ghpsj.fr

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical-microbiological course of lung transplant patients treated for Stenotrophomonas maltophilia pneumonia
Time Frame: Day 1
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistance rate of Stenotrophomonas maltophilia strains
Time Frame: Day 1
This outcome corresponds to the Trimethorpime/sulfamethoxazole resistance rate of Stenotrophomonas maltophilia strains.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 31, 2021

First Submitted That Met QC Criteria

December 31, 2021

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STENO_SOT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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