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De klinische studie NCT06788769 voor Clostridioides difficile-infectie is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Study of Clostridioides Difficile in Infants 300 Biomarker-gedreven Preventief
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De klinische studie NCT06788769 is een observationeel studie bij Clostridioides difficile-infectie met de status rekruterend. Het doel is om 300 deelnemers te includeren vanaf 1 juli 2024. De studie wordt geleid door Westlake University en de voltooiing is gepland op 30 december 2026. Laatste update op ClinicalTrials.gov: 23 januari 2025.
Beknopte samenvatting
Clostridioides difficile infection (CDI) poses an increasing threat to infant and young child health, with detection rates rising annually. This retrospective study aims to explore the epidemiological characteristics, clinical manifestations, and potential biomarkers of CDI in children aged 0-2 years by examining three cohorts: (1) infants diagnosed with CDI, (2) asymptomatic carriers of C. difficile, and (3) healthy...Toon meer
Officiële titel
Retrospective Analysis of Risk Factors and Microbiome Alterations in Infant Clostridioides Difficile Infection
Aandoeningen
Clostridioides difficile-infectieAndere studie-ID's
- 20241202TL001
NCT-ID
Startdatum (Werkelijk)
2024-07-01
Laatste update geplaatst
2025-01-23
Verwachte einddatum
2026-12-30
Inschrijving (Geschat)
300
Studietype
Observationeel
Status
Rekruterend
Trefwoorden
Clostridioides Difficile
Infants
Infants
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
CDI Patients This group includes infants aged 0-2 years who have been diagnosed with Clostridioides difficile infection (CDI). Diagnosis is based on clinical symptoms such as diarrhea, abdominal pain, or fever, along with positive laboratory confirmation (e.g., stool PCR or culture for C. difficile). | N.v.t. |
Asymptomatic Clostridioides difficile Carriers This group includes infants aged 0-2 years who are colonized with Clostridioides difficile but show no clinical symptoms of infection. Participants in this group tested positive for C. difficile in fecal samples collected during routine or study-related screening. | N.v.t. |
Healthy Infants This group includes infants aged 0-2 years who do not show any clinical symptoms of infection and have tested negative for Clostridioides difficile in fecal samples. Participants were recruited from general pediatric clinics or community health programs. | N.v.t. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Prevalence of Clostridioides difficile infection (CDI) and asymptomatic carriage in infants | The prevalence of CDI and asymptomatic C. difficile carriage will be determined by testing fecal samples for C. difficile using PCR and/or culture methods. Participants are categorized into three groups based on clinical symptoms (diarrhea, abdominal pain, or fever) and laboratory confirmation (positive PCR or stool culture).
Specifically, the primary outcome assesses:
1. The proportion of infants (0-2 years) testing positive for C. difficile who exhibit clinical symptoms (CDI patients).
2. The proportion of infants (0-2 years) testing positive but showing no symptoms (asymptomatic carriers), and the proportion of infants testing negative (healthy controls). | Data from medical records and stool sample tests collected retrospectively between July 2024 and December 2026. |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Gut Microbial Diversity Among CDI Patients, Asymptomatic Carriers, and Healthy Controls | Metagenomic sequencing will be performed on fecal samples to assess alpha and beta diversity.The goal is to compare microbial community shifts and identify specific taxa changes associated with CDI. | Same retrospective collection period (2024-2026) |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind
Minimumleeftijd
1 Day
Geslachten die in aanmerking komen voor de studie
Allen
Age Range: Infants aged 0 to 2 years (inclusive) at the time of sample collection or medical record documentation.
Data Availability: Complete medical records or available stool samples within the study's retrospective time frame.
Group-Specific Criteria:
CDI Patients: Documented diarrhea or related gastrointestinal symptoms, with laboratory-confirmed C. difficile by PCR or culture.
Asymptomatic Carriers: Positive C. difficile test (PCR or culture) in the absence of diarrhea or other clinical CDI symptoms.
Healthy Controls: Negative C. difficile test and no gastrointestinal symptoms indicative of CDI.
Consent/Authorization:Retrospective data (e.g., existing medical records or stored biosamples) may be included under a waiver of consent if approved by the institutional review board (IRB). However, any new information obtained directly from participants or their guardians (e.g., via questionnaires) requires explicit informed consent.
- Incomplete Data: Infants whose medical records lack sufficient information to confirm their CDI status or those without adequate stool sample results.
- Ambiguous Diagnosis: Patients presenting with other infectious diseases or conditions that could not rule out alternative diagnoses for diarrhea (e.g., confirmed concurrent viral or parasitic infections) without conclusive C. difficile testing.
- Severe Comorbidities: Infants with life-threatening congenital conditions (e.g., severe immunodeficiency syndromes) if these conditions significantly alter the gut microbiota or confound CDI diagnosis.
Westlake UniversityCentraal Contactpersoon
Contact: Liang Tao, PHD, 86-19817412816, [email protected]
Contact: Liqian Wang, 86-18768156110, [email protected]
1 Studielocaties in 1 landen
Zhejiang
Hangzhou First People's Hospital, Hangzhou, Zhejiang, 310000, China
Liqian Wang, Contact, 86-18768156110, [email protected]
Rekruterend