Actively Recruiting
Retrospective Cohort Study on Epidemiology and Biomarkers of Clostridium Difficile Infection in Infants
Led by First People's Hospital of Hangzhou · Updated on 2024-11-25
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
First People's Hospital of Hangzhou
Lead Sponsor
W
Westlake University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand Clostridium difficile infection (CDI) in infants up to 2 years old by studying past medical data and patient questionnaires. It focuses on identifying how common CDI is in this group, what risk factors increase the chance of infection, and what biomarkers can help detect the infection early. This observational study hopes to improve diagnosis and treatment for young children affected by CDI. The study compares two groups: infants diagnosed with CDI and those without the infection. Researchers will analyze medical records and questionnaire data from both groups to find differences in epidemiological characteristics and biomarkers linked to CDI. There are no new treatments given, as this is a retrospective review of existing information. Participants' involvement includes the use of their historical medical records and questionnaire responses to identify high-risk factors and biomarkers related to CDI. The main outcome measured is the number of infants with identified risk factors for CDI over a review period of up to 12 months after diagnosis. Additional outcomes include identifying biomarkers and validating a mouse model for CDI research. The study spans data collection and analysis up to 18 months.
CONDITIONS
Brief Title
Study on Clostridium Difficile Infection in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants aged 0 to 24 months
- Medical records and patient questionnaires available
- Confirmed Clostridium difficile infection diagnosis for the case group or no infection for the control group
You will not qualify if you...
- Infants older than 24 months at the time of diagnosis
- Incomplete medical records or missing key information about infection status, feeding, or antibiotic use
- Presence of other severe gastrointestinal conditions that could affect results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Retrospective data review from medical records and patient questionnaires
Duration - Retrospective review covering initial exposure to 12 months post-diagnosis
Participants' medical records are reviewed to confirm Clostridium difficile infection status or absence of infection, identifying cases and controls.
No additional visits; data analysis only
Duration - Up to 12 months post last sample collection
Participants' data are monitored retrospectively to identify high-risk factors and biomarkers associated with Clostridium difficile infection.
No participant visits; retrospective observation only
Trial Site Locations
Total: 1 location
1
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, China, 310006
Actively Recruiting
Research Team
L
Li Qian Wang, Master of Medicine
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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