Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05193058
Other study ID # STENO_SOT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 22, 2021
Est. completion date December 31, 2023

Study information

Verified date April 2023
Source Groupe Hospitalier Paris Saint Joseph
Contact Benoit PILMIS, MD
Phone 144127820
Email bpilmis@ghpsj.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 31, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Groupe Hospitalier Paris Saint-Joseph Paris

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 1
Secondary Resistance rate of Stenotrophomonas maltophilia strains This outcome corresponds to the Trimethorpime/sulfamethoxazole resistance rate of Stenotrophomonas maltophilia strains. Day 1
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05047406 - Bacillus Clausii in Liver Transplantation Phase 2
Completed NCT02463214 - Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients N/A
Recruiting NCT05198570 - Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Completed NCT01808456 - Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant. Phase 4
Suspended NCT01301118 - Graft Take and Microbiology in Burns N/A
Completed NCT00610961 - Induction Related BK Viremia in Renal Transplant Patients Phase 4
Recruiting NCT05215327 - High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients Phase 2
Unknown status NCT01983761 - Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation Phase 1/Phase 2
Active, not recruiting NCT02811835 - TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN) N/A
Completed NCT01471444 - Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Phase 3
Enrolling by invitation NCT01349738 - Asymptomatic Bacteriuria & Risk of Urinary Tract Infection in Renal Transplants N/A
Terminated NCT00473824 - Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation Phase 2
Completed NCT00177801 - Organ Transplant Infection Prevention and Detection Project Phase 4
Completed NCT01276457 - Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients Phase 3
Completed NCT02328963 - Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A Phase 4
Recruiting NCT04320303 - CMV Infection and Immune Intervention After Transplantation N/A
Active, not recruiting NCT01295645 - Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis Phase 2
Completed NCT02329808 - Clinical Validation of a Dried Blood Spot Method for Analysis of Immunosuppressives and Antifungals in Pediatrics
Completed NCT01471067 - Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies Phase 1
Recruiting NCT04579471 - Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in Transplant Recipients: The COVITRA Study