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Clinical investigation on the diagnosis of recurrent Clostridium difficile infection based on gut metagenomic multi-pathogen

Clinical investigation on the diagnosis of recurrent Clostridium difficile infection based on gut metagenomic multi-pathogen

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119033
Enrollment
Unknown
Registered
2026-02-14
Start date
2025-01-03
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium difficile–associated diarrhea (CDAD)

Interventions

Observation group :None

Sponsors

Zhongshan Hospital Affiliated with Fudan University?
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Has provided written informed consent to participate in the study; 2. Aged 18 years or older; 3. Clinical manifestations: unformed diarrhea (> 3 episodes per 24 hours), fever, abdominal pain, abdominal distension; diarrhea initially watery, which may later progress to mucoid or bloody stools, accompanied by leukocytosis. Severe infection presents as watery diarrhea with dehydration, toxic colitis, and sepsis; mucus may be present in the stool.

Exclusion criteria

Exclusion criteria: 1. Sample is contaminated or suspected to be contaminated, or shows significant hemolysis or lipemia; 2. Patient without diarrhea; 3. Sample does not meet testing requirements (e.g., insufficient quantity, lost sample, etc.); 4. Repeated sampling from the same case; 5. Incomplete or non-standard basic sample information (including, but not limited to, subject traceability ID, pathological diagnosis/clinical diagnosis), such as missing key traceability information or unclear diagnostic details.

Design outcomes

Primary

MeasureTime frame
Positive Agreement Rate;Negative Agreement Rate:;Overall Agreement Rate?;Positive Predictive Value;Negative predictive value;

Countries

China

Contacts

Public ContactYuan Ji

Zhongshan Hospital Affiliated with Fudan University?

823321266@qq.com+86 21 6404 1990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026