Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 6:43 PM
Study NCT ID:
NCT07052604
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Treatment for Pneumonia Caused by Stenotrophomonas Maltophilia in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient survival based on the antibiotic treatment strategy used (monotherapy vs. combination therapy and 7 vs. 14 days duration).', 'timeFrame': '28 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia, Ventilator-Associated', 'Stenotrophomonas Maltophilia', 'Intensive Care Units', 'Anti-Bacterial Agents', 'Drug Resistance, Bacterial']}, 'descriptionModule': {'briefSummary': 'This study looks at how different antibiotic treatments affect patients in intensive care who have pneumonia caused by the bacteria Stenotrophomonas maltophilia. It compares using one antibiotic versus two antibiotics, and treatment lengths of 7 days versus 14 days, to see which approach helps patients survive better. The study also examines how resistant the bacteria are to antibiotics and how often the pneumonia comes back.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients admitted to the Medical Intensive Care Unit (ICU) between January 2018 and December 2023 who are intubated and mechanically ventilated, and who develop ventilator-associated pneumonia caused by Stenotrophomonas maltophilia. These patients represent a critical care group at high risk for serious infections with multidrug-resistant bacteria.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years)\n* Hospitalized in Medical Intensive Care Unit between January 1, 2018, and December 31, 2023\n* Intubated and mechanically ventilated\n* Diagnosed with ventilator-associated pneumonia caused by Stenotrophomonas maltophilia\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients who refuse the use of their data for research purposes'}, 'identificationModule': {'nctId': 'NCT07052604', 'briefTitle': 'Antibiotic Treatment for Pneumonia Caused by Stenotrophomonas Maltophilia in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Saint-Denis'}, 'officialTitle': 'Antibiotic Treatment for Pneumonia Caused by Stenotrophomonas Maltophilia in ICU Patients', 'orgStudyIdInfo': {'id': '0055_STENO'}}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Denis', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nolan HASSOLD', 'role': 'CONTACT', 'email': 'coordination.rechercheclinique@ghtpdfr.fr', 'phone': '0142356208'}], 'facility': 'Centre Hospitalier de Saint-Denis', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Saint-Denis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}