Study on Clostridium Difficile Infection in Infants

November 21, 2024 updated by: First People's Hospital of Hangzhou

A Retrospective Cohort Study on the Epidemiological Characteristics and Biomarkers of Clostridium Difficile Infection in Infants

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang, China
      • Hangzhou, Zhejiang, China, China, 310006
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:
        • Contact:
          • Jianhua Luo, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case Group
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.
Control Group
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Collaborators

Westlake University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-20240613-0201-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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