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Die klinische Studie NCT06788769 für Clostridioides-difficile-Infektion ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Study of Clostridioides Difficile in Infants 300 Biomarker-basiert Präventiv

Offene Rekrutierung
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Die klinische Studie NCT06788769 ist eine beobachtungsstudie zur Untersuchung von Clostridioides-difficile-Infektion und hat den Status offene rekrutierung. Die Studie startete am 1. Juli 2024 und soll 300 Teilnehmer aufnehmen. Durchgeführt von Westlake University ist der Abschluss für 30. Dezember 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 23. Januar 2025 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Offizieller Titel

Retrospective Analysis of Risk Factors and Microbiome Alterations in Infant Clostridioides Difficile Infection

Erkrankungen
Clostridioides-difficile-Infektion
Weitere Studien-IDs
  • 20241202TL001
NCT-Nummer
NCT06788769
Studienbeginn (tatsächlich)
2024-07-01
Zuletzt aktualisiert
2025-01-23
Studienende (vorauss.)
2026-12-30
Geplante Rekrutierung
300
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Stichwörter
Clostridioides Difficile
Infants
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
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).
Nicht zutreffend
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.
Nicht zutreffend
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.
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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)
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind
Mindestalter
1 Day
Zugelassene Geschlechter
Alle

  1. Age Range: Infants aged 0 to 2 years (inclusive) at the time of sample collection or medical record documentation.

  2. Data Availability: Complete medical records or available stool samples within the study's retrospective time frame.

  3. 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.

  4. 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.

  1. Incomplete Data: Infants whose medical records lack sufficient information to confirm their CDI status or those without adequate stool sample results.
  2. 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.
  3. 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 University logoWestlake University
Zentrale Studienkontakte
Kontakt: Liang Tao, PHD, 86-19817412816, [email protected]
Kontakt: Liqian Wang, 86-18768156110, [email protected]
1 Studienstandorte in 1 Ländern

Zhejiang

Hangzhou First People's Hospital, Hangzhou, Zhejiang, 310000, China
Liqian Wang, Kontakt, 86-18768156110, [email protected]
Offene Rekrutierung