Study on Clostridium Difficile Infection in Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Clostridium Difficile Infection. Basic parameters: 0 months — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Retrospective Cohort Study on the Epidemiological Characteristics and Biomarkers of Clostridium Difficile Infection in Infants
Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Hangzhou First People's Hospital — Hangzhou
Identifiers
NCT: NCT06703918 · KY-20240613-0201-01