Study on Clostridium Difficile Infection in Infants

NCT06703918 | Recruiting

• 1 other identifier: KY-20240613-0201-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile; Infants; Epidemiology; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Number of Infants With Identified High-Risk Factors for Clostridium difficile Infection (CDI)

  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 Outcomes (2)

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• Westlake University: collaborator

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China, 310006, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

feces

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Li Qian Wang, Master of Medicine

CONTACT

86+18768156110; wanglq921206@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 25, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)