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

Transplantation Infection Clinical Trial

— STENO_SOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193058
• Other study ID #: STENO_SOT
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Pneumonia
• Transplantation Infection

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

External Links

•   Clinical and microbiological characteristics of patients colonized or infected by Stenotrophomonas maltophilia : is resistance to sulfamethoxazole/trimethoprim a problem?