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Evaluation of the Diagnostic Performance of Multiplex Droplet Digital PCR for Detecting Bloodstream Infection Pathogens in Patients with Hematologic Diseases: A Diagnostic Clinical Study

Evaluation of the Diagnostic Performance of Multiplex Droplet Digital PCR for Detecting Bloodstream Infection Pathogens in Patients with Hematologic Diseases: A Diagnostic Clinical Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108340
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Hematological diseases and bloodstream infections

Interventions

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, male or female; 2. Complete digital PCR and blood culture examinations at the same time during the patient's admission 3. Clinical suspicion of bloodstream infection (at least 1 of the following): (1) Body temperature >=38.3°C or =0.5ng/mL or C-reactive protein (CRP) >=50mg/L; (3) Clinicians determine that blood culture examination is required; (4) BSI-related risk factors.

Exclusion criteria

Exclusion criteria: 1. Patients with non-hematological diseases; 2. Patients with incomplete general information, patients who are lost to follow-up, and patients who refuse to participate in the experiment; 3. Other situations that are not included or need to be excluded.

Design outcomes

Primary

MeasureTime frame
Digital PCR copy number;Blood culture results;Survival status;

Secondary

MeasureTime frame
Procalcitonin;C-reactive protein;Cytokines;body temperature;

Countries

China

Contacts

Public ContactJingjing Liu

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

20243139@zcmu.edu.cn+86 183 6813 8576

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026