Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
Study NCT ID:
NCT05880069
Status:
UNKNOWN
Last Update Posted:
2023-05-30
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcomes in Patients With Infection by Resistant Microorganism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D002481', 'term': 'Cellulitis'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D004927', 'term': 'Escherichia coli Infections'}, {'id': 'D000151', 'term': 'Acinetobacter Infections'}, {'id': 'D011552', 'term': 'Pseudomonas Infections'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D045828', 'term': 'Moraxellaceae Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-18', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Death any time after infection, during the follow-up time of the original study.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with ICU admission', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Need for an admission in ICU setting for more than 24 hours after infection onset.'}, {'measure': 'Number of participants with clinical cure', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Absence of symptoms after completion of an antibiotic treatment course.'}, {'measure': 'Number of participants with microbiological cure', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'No isolation of the causal microorganisms after completion of an antibiotic treatment course.'}, {'measure': 'Number of participants with recurrence of infection', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Infection with the same organism after more than two weeks of the initial infection.'}, {'measure': 'Number of participants with superinfection', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Other infections different from the one under assessment.'}, {'measure': 'Number of participants with cognitive impairment / disability', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Impairment is any temporal or permanent loss of function; disability is a restriction or inability to perform a normal activity resulting from an impairment. Assessed using Center for Epidemiologic Studies Depression Scale (CES-D), Mini-Mental State Examination (MMSE) or Trail Making Test (TMT).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pneumonia', 'Bloodstream Infection', 'Urinary Tract Infections', 'Skin Infection', 'Surgical Site Infection', 'Staphylococcus Aureus', 'Klebsiella Pneumonia', 'Escherichia Coli', 'Enterococcus Faecium Infection', 'Acinetobacter Infections', 'Pseudomonas Aeruginosa']}, 'descriptionModule': {'briefSummary': 'The goal of this individual patient data meta-analysis is to estimate the attributed and the associated health burden related to bloodstream infections, pneumonia, skin and soft tissue infections, surgical site infections and urinary tract infections, caused by target drug-resistant pathogens, in high income countries.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Are common infections caused by drug-resistant pathogens associated with an increased health burden, when compared with individuals with the same infection caused by a susceptible strain (attributed burden)?\n* Are common infections caused by drug-resistant pathogens associated with an increase health burden, when compared with individuals without the infection under study (associated burden)?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Individuals of all ages with the target pathogen, resistance phenotype, and infection site combinations as follows:\n\n * P. aeruginosa, carbapenems resistant: BSI\n * A. baumannii, carbapenems resistant: BSI\n * E. coli, 3rd generation cephalosporins resistant: BSI and UTI\n * K. pneumoniae, 3rd generation cephalosporins resistant: BSI\n * K. pneumoniae, carbapenems resistant: BSI\n * S. aureus, methicillin resistant: BSI, pneumonia, SSI and SSTI\n * E faecium, vancomycin resistant: BSI\n * Enterobacterales, 3rd generation cephalosporins resistant: BSI\n2. Individuals of all ages with the same infection caused by the target drug-susceptible pathogen\n3. Individuals of all ages without the infection under study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals of all ages\n* Individuals with hospital acquired, community acquired, or healthcare associated infections\n* Individuals treated at hospital level, community, or long-term care facilities\n* Individuals with the targeted pathogen, resistance phenotype, and infection site combinations under study\n\nExclusion Criteria:\n\n* Individuals with infections in the following systems: central nervous system, genital system, pelvic infections and head and neck infections\n* Individuals with the following specific primary infections: endocarditis, upper respiratory tract infections, lung abscess\n* Individuals with bacterial infections not included in the table of pathogens of interest, polymicrobial infections except for intraabdominal infections, fungal infections, parasitic infections, viral infections, mycobacterial infections, sexually transmitted diseases, and zoonotic infections'}, 'identificationModule': {'nctId': 'NCT05880069', 'briefTitle': 'Clinical Outcomes in Patients With Infection by Resistant Microorganism', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Virgen Macarena'}, 'officialTitle': 'Clinical Outcomes in Patients With Infection by Resistant Microorganism', 'orgStudyIdInfo': {'id': 'PRIMAVERA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Drug-resistant pathogen', 'description': 'Individuals of all ages with the target pathogen, resistance phenotype, and infection site combinations as follows:\n\n1. P. aeruginosa, carbapenems resistant: BSI\n2. A. baumannii, carbapenems resistant: BSI\n3. E. coli, 3rd generation cephalosporins resistant: BSI and UTI\n4. K. pneumoniae, 3rd generation cephalosporins resistant: BSI\n5. K. pneumoniae, carbapenems resistant: BSI\n6. S. aureus, methicillin resistant: BSI, pneumonia, SSI and SSTI\n7. E faecium, vancomycin resistant: BSI\n8. Enterobacterales, 3rd generation cephalosporins resistant: BSI', 'interventionNames': ['Other: Pathogen resistant phenotype']}, {'label': 'Drug-susceptible pathogen', 'description': 'Individuals of all ages with the target pathogen, susceptible phenotype, and infection site combinations as follows:\n\n1. P. aeruginosa, carbapenems susceptible: BSI\n2. A. baumannii, carbapenems susceptible: BSI\n3. E. coli, 3rd generation cephalosporins susceptible: BSI and UTI\n4. K. pneumoniae, 3rd generation cephalosporins susceptible: BSI\n5. K. pneumoniae, carbapenems susceptible: BSI\n6. S. aureus, methicillin susceptible: BSI, pneumonia, SSI and SSTI\n7. E faecium, vancomycin susceptible: BSI\n8. Enterobacterales, 3rd generation cephalosporins susceptible: BSI', 'interventionNames': ['Other: Pathogen resistant phenotype']}, {'label': 'No infection', 'description': 'Individuals of all ages without the infection under study'}], 'interventions': [{'name': 'Pathogen resistant phenotype', 'type': 'OTHER', 'description': 'Drug resistant phenotype of the target pathogen under study', 'armGroupLabels': ['Drug-resistant pathogen', 'Drug-susceptible pathogen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Jesús Rodríguez-Baño, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Virgen Macarena', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}