Study on Clostridium Difficile Infection in Infants

Recruiting

• Conditions: Clostridium Difficile Infection

• Registration Number: NCT06703918
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Infants With Identified High-Risk Factors for Clostridium difficile Infection (CDI)	Retrospective data review spanning from initial exposure to Clostridium difficile infection up to 12 months post-diagnosis.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Identified Biomarkers Associated With Clostridium difficile Infection in Infants	From the initiation of the study until 12 months after the last sample collection	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.
Validation of Experimental Mouse Model for Clostridium difficile Infection and Biomarker Identification	From the initiation of the study until completion of biomarker identification, approximately 18 months	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.

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China, China