Clinical evaluation of droplet digital PCR in early diagnosis and treatment for suspected sepsis in emergency department

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200065015

Enrollment

Unknown

Registered

2022-10-25

Start date

2022-10-28

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

sepsis

Interventions

Gold Standard:blood culture

Index test:droplet digital PCR

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. modified Shapiro score.=2 (Main criteria: suspected infective endocarditis 2 score; Temperature >39.4 degree 3 score; Indwelling catheter 3 score) (Minor criteria:Age >65 1 score;Temperature 38.3-39.3 degree 1 score;chilliness 1 score;Hypotension (systolic blood pressure 176.8mmol/l 1 score ) 2. Age>=18years, both sexes 3. Informed consent was obtained and the informed consent was signed

Exclusion criteria

Exclusion criteria: 1. ICU time was less than 24 hours 2. HIV patients or malignant tumors 3. Pregnant and lactating women 4. Participated in other clinical studies 5. No informed consent was signed

Design outcomes

Primary

Measure	Time frame
Sensitivity;Specificity;	—

Secondary

Measure	Time frame
The sequential organ failure assessment score (SOFA score);Time to the change to the targeted antimicrobial therapy;Duration of antimicrobials;	—

Countries

China

Contacts

Public Contactlunxian Tang

Shanghai East Hospital (East Hospital Affiliated to Tongji University)

456tlx@163.com18916290981

Outcome results

None listed

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