Clostridium Difficile InfectionNCT06703918
Study on Clostridium Difficile Infection in Infants
An observational study of Clostridium Difficile Infection, run by First People's Hospital of Hangzhou at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 24 months
- Conditions the study is for
- Clostridium Difficile Infection
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 months
- All sexes
- Child
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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Li Qian Wang, M.Med, 86+18768156110, wanglq921206@163.com
Jianhua Luo, PHD
About this study
Official title: A Retrospective Cohort Study on the Epidemiological Characteristics and Biomarkers of 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.
Read the 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.
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile, Infants, Epidemiology, Biomarkers
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: From the initiation of the study until completion of biomarker identification, approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Jul 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703918
- Sponsor's protocol ID
- KY-20240613-0201-01
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study on the Epidemiological Characteristics and Biomarkers of Clostridium Difficile Infection in Infants
- ClinicalTrials.gov ID
- NCT06703918
- Acronym / sponsor ID
- KY-20240613-0201-01
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile, Infants, Epidemiology, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Westlake University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Qian Wang, Master of Medicine (86+18768156110, wanglq921206@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024; AzTrials last refreshed its copy on 28 Oct 2026.