Study on Clostridium Difficile Infection in Infants

NCT ID: NCT06703918

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-12-30

Brief Summary

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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

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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.

Conditions

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Clostridium Difficile Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

0 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Westlake University

OTHER

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hangzhou First People's Hospital

Hangzhou, Zhejiang, China, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Qian Wang, Master of Medicine

Role: CONTACT

86+18768156110

Facility Contacts

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Li Qian Wang, M.Med

Role: primary

86+18768156110

Jianhua Luo, PHD

Role: backup

Other Identifiers

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KY-20240613-0201-01

Identifier Type: -

Identifier Source: org_study_id

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