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NCT Number: NCT06703918

Study on Clostridium Difficile Infection in Infants

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.

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

0 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China, 310006, China

Location status: Recruiting

Location contact

Jianhua Luo, PHD

CONTACT

Li Qian Wang, M.Med

CONTACT

[email protected]

86+18768156110

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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

    This measure reports the number of specific biomarkers identified from collected biological samples that are associated with Clostridium difficile infection in infants and young children. Biomarkers include bacterial taxa, metabolites, and other biological indicators relevant to infection susceptibility and disease progression. These biomarkers will be analyzed to evaluate their potential roles as risk factors, diagnostic indicators, and predictors of disease outcomes.

  2. 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

    This measure involves the validation of an experimental mouse model designed to simulate Clostridium difficile infection and identify key biomarkers associated with infection risk in infants. The validation process includes assessing the mouse model's effectiveness in replicating human disease conditions, such as microbiota composition and immune response. Specific biomarkers, including bacterial taxa, host immune markers, and metabolites, will be analyzed to evaluate the model's relevance for further biomarker discovery and translational research.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Qian Wang, Master of Medicine

CONTACT

[email protected]

86+18768156110

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Collaborators

  • Westlake University

Registry information

Official study title

A Retrospective Cohort Study on the Epidemiological Characteristics and Biomarkers of Clostridium Difficile Infection in Infants

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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