Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT05193058
Status:
UNKNOWN
Last Update Posted:
2023-04-27
First Post:
2021-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Description of Lung Transplant Patients With Microbiologically Documented Stenotrophomonas Maltophilia Pneumonia and Impact of Treatment on Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2021-12-31', 'studyFirstSubmitQcDate': '2021-12-31', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical-microbiological course of lung transplant patients treated for Stenotrophomonas maltophilia pneumonia', 'timeFrame': 'Day 1', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Resistance rate of Stenotrophomonas maltophilia strains', 'timeFrame': 'Day 1', 'description': 'This outcome corresponds to the Trimethorpime/sulfamethoxazole resistance rate of Stenotrophomonas maltophilia strains.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transplantation Infection']}, 'referencesModule': {'references': [{'pmid': '9457429', 'type': 'BACKGROUND', '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.'}, {'pmid': '12032905', 'type': 'BACKGROUND', '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.'}, {'pmid': '32082659', 'type': 'BACKGROUND', '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.'}, {'pmid': '32122208', 'type': 'BACKGROUND', '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.'}, {'pmid': '22057419', 'type': 'BACKGROUND', '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.'}, {'pmid': '31427295', 'type': 'BACKGROUND', '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.'}, {'pmid': '26388847', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients managed for Stenotrophomonas maltophilia pneumonia following a lung or heart-lung transplant between 01/01/2011 and 01/01/2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient whose age ≥ 18 years\n* Patient who has received a lung (mono or bi-pulmonary) or heart-lung transplant\n* Patient with documented pneumopathy (clinico-radiological definition) (positive respiratory specimen for Stenotrophomonas maltophilia)\n* French speaking patient\n\nExclusion Criteria:\n\n* Patient under guardianship or curatorship\n* Patient deprived of liberty\n* Patient under court protection\n* Patient objecting to the use of his data for this research'}, 'identificationModule': {'nctId': 'NCT05193058', 'acronym': 'STENO_SOT', 'briefTitle': 'Description of Lung Transplant Patients With Microbiologically Documented Stenotrophomonas Maltophilia Pneumonia and Impact of Treatment on Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Description of Lung Transplant Patients With Microbiologically Documented Stenotrophomonas Maltophilia Pneumonia and Impact of Treatment on Outcome', 'orgStudyIdInfo': {'id': 'STENO_SOT'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoit PILMIS, MD', 'role': 'CONTACT'}], 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Benoit PILMIS, MD', 'role': 'CONTACT', 'email': 'bpilmis@ghpsj.fr', 'phone': '144127820', 'phoneExt': '+33'}, {'name': 'Helene BEAUSSIER', 'role': 'CONTACT', 'email': 'crc@ghpsj.fr', 'phone': '0144127883', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Benoit PILMIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}