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Metagenomic next-generation sequencing in the differential diagnosis and clinical decision-making of patients with fever of unknown origin (FUO)

Metagenomic next-generation sequencing in the differential diagnosis and clinical decision-making of patients with fever of unknown origin (FUO)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123917
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-06
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Fever

Interventions

The fever observation group:None

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Gender: No restrictions on gender; 3. Research participants who were admitted to Huashan Hospital from March 1, 2026 to January 31, 2028, and meet one of the following diagnoses: (1) Classic fever of unknown origin: Fever persists for more than 3 weeks, oral temperature exceeds 38.3 ? at least 3 times (or the temperature fluctuates by more than 1.2 ? within 1 day) after at least 1 week of outpatient or inpatient condition assessment, and the diagnosis remains unclear; (2) Fever of unknown origin for hospitalized participants: No fever at admission, and fever persists for more than 3 days after admission, oral temperature exceeds 38.3 ? at least 3 times or the temperature fluctuates by more than 1.2 ? within 1 day; (3) Fever of unknown origin with granulocyte deficiency: Absolute neutrophil count is less than 0.5*10^9/L; Fever persists for more than 3 days, oral temperature exceeds 38.3 ? at least 3 times or the temperature fluctuates by more than 1.2 ? within 1 day; The culture results of body fluid specimens are negative after more than 48 hours of incubation; 4. Routine clinical sample submission for targeted genomic sequencing and metagenomic sequencing (including blood, bronchoalveolar lavage fluid, cerebrospinal fluid, lung tissue, etc.); 5. Complete clinical data; 6. Understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The quality of the sample or sequencing data does not meet the standards; 2. Pregnant women; 3. Lack of key clinical information or dropouts.

Design outcomes

Primary

MeasureTime frame
Copy number variation;

Countries

China

Contacts

Public ContactJiachun Su

Huashan Hospital Affiliated to Fudan University

jcsu@fudan.edu.cn+86 21 5288 8195

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026