Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT06703918
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2024-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Clostridium Difficile Infection in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'feces'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Infants With Identified High-Risk Factors for Clostridium difficile Infection (CDI)', 'timeFrame': 'Retrospective data review spanning from initial exposure to Clostridium difficile infection up to 12 months post-diagnosis.', 'description': 'This measure reports the number of infants with high-risk factors associated with Clostridium difficile infection (CDI), as assessed by data on feeding methods, antibiotic use, and environmental exposures. Quantitative data will be analyzed to identify correlations and trends.'}], 'secondaryOutcomes': [{'measure': 'Number of Identified Biomarkers Associated With Clostridium difficile Infection in Infants', 'timeFrame': 'From the initiation of the study until 12 months after the last sample collection', 'description': 'This measure reports the number of specific biomarkers identified from collected biological samples that are associated with Clostridium difficile infection in infants and young children. Biomarkers include bacterial taxa, metabolites, and other biological indicators relevant to infection susceptibility and disease progression. These biomarkers will be analyzed to evaluate their potential roles as risk factors, diagnostic indicators, and predictors of disease outcomes.'}, {'measure': 'Validation of Experimental Mouse Model for Clostridium difficile Infection and Biomarker Identification', 'timeFrame': 'From the initiation of the study until completion of biomarker identification, approximately 18 months', 'description': "This measure involves the validation of an experimental mouse model designed to simulate Clostridium difficile infection and identify key biomarkers associated with infection risk in infants. The validation process includes assessing the mouse model's effectiveness in replicating human disease conditions, such as microbiota composition and immune response. Specific biomarkers, including bacterial taxa, host immune markers, and metabolites, will be analyzed to evaluate the model's relevance for further biomarker discovery and translational research."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clostridium difficile', 'Infants', 'Epidemiology', 'Biomarkers'], 'conditions': ['Clostridium Difficile Infection']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the epidemiological characteristics and biomarkers of Clostridium difficile infection in infants . By analyzing historical medical data and patient questionnaires, this retrospective cohort study will identify potential high-risk factors and establish baseline biomarkers to improve diagnosis and treatment for affected patients.', 'detailedDescription': 'This retrospective cohort study focuses on Clostridium difficile infection (CDI) in infants n, a relatively rare infection. The study will utilize data from hospital and community to identify the prevalence, risk factors, and unique biomarkers associated with CDI in pediatric patients. Key objectives include: (1) analyzing demographic and clinical characteristics of affected patients, (2) evaluating the high-risk factors of CDI, and (3) identifying biomarkers that can aid in early detection and treatment planning. Findings from this study are expected to contribute to the improvement of CDI management in pediatric care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '0 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infants diagnosed with Clostridium difficile infection, along with age-matched control subjects without infection, recruited from affiliated hospitals and society. Participants will be selected based on inclusion and exclusion criteria to ensure a representative sample for studying infection risk factors and biomarker discovery in this population', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants ( aged 0-2 years). Medical records and patient questionnaires available with confirmed Clostridium difficile infection (for case group) or without infection (for control group).\n\nExclusion Criteria:\n\n* Infants beyond the age of 2 years at the time of diagnosis. Incomplete medical records or missing essential information related to infection status, feeding methods, or antibiotic exposure.Patients with other severe gastrointestinal conditions that may confound results.'}, 'identificationModule': {'nctId': 'NCT06703918', 'briefTitle': 'Study on Clostridium Difficile Infection in Infants', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'A Retrospective Cohort Study on the Epidemiological Characteristics and Biomarkers of Clostridium Difficile Infection in Infants', 'orgStudyIdInfo': {'id': 'KY-20240613-0201-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case Group', 'description': 'This group includes infants and young children diagnosed with Clostridium difficile infection (CDI). Participants in this group have been identified based on medical records andpatient questionnaires showing confirmed CDI diagnosis. This group will be analyzed for epidemiological characteristics and biomarkers associated with CDI.'}, {'label': 'Control Group', 'description': 'This group includes infants and young children without Clostridium difficile infection (CDI). These participants have no record of CDI diagnosis and serve as the control group to identify risk factors and biomarkers by comparing with the case group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang, China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Qian Wang, M.Med', 'role': 'CONTACT', 'email': 'wanglq921206@163.com', 'phone': '86+18768156110'}, {'name': 'Jianhua Luo, PHD', 'role': 'CONTACT'}], 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Li Qian Wang, Master of Medicine', 'role': 'CONTACT', 'email': 'wanglq921206@163.com', 'phone': '86+18768156110'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'collaborators': [{'name': 'Westlake University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}