Clinical trial NCT06703918: Study on Clostridium Difficile Infection in Infants
Official title: A Retrospective Cohort Study on the Epidemiological Characteristics and Biomarkers of Clostridium Difficile Infection in Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile
Infants
Epidemiology
Biomarkers
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: Westlake University
First posted: 2024-11-25
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Primary outcomes:
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.
Secondary outcomes:
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
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
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang, China
Study officials:
References: