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Using digital PCR method on the rapid diagnosis, precise treatment and efficacy evaluation of ICU patients with suspected bloodstream infections: a prospective, multicenter, parallel-controlled study

Using digital PCR method on the rapid diagnosis, precise treatment and efficacy evaluation of ICU patients with suspected bloodstream infections: a prospective, multicenter, parallel-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116655
Enrollment
Unknown
Registered
2026-01-13
Start date
2020-02-15
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Bloodstream infection

Interventions

Observation group:None

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ICU hospitalized patients with an APACHE II score greater than 8; 2. Clinical signs of infection, with a body temperature above 38°C or below 36°C, possibly accompanied by chills, along with one of the following symptoms: (1) Presence of an invasive portal or migrating focus of infection; (2) General toxic symptoms without a clear focus of infection; (3) Rash with petechiae, hepatomegaly or splenomegaly, increased neutrophils in the blood with a left shift, with no other explanation; (4) Systolic blood pressure below 90 mmHg or a decrease of 40 mmHg from baseline, and SOFA score > 2; 3. Age > 18 years.

Exclusion criteria

Exclusion criteria: 1. Individuals on the verge of death or those who fail resuscitation from severe shock; 2. Patients with severe liver and kidney dysfunction; 3. Patients in the terminal stage of malignant tumors.

Design outcomes

Secondary

MeasureTime frame
Duration of Antibiotic Treatment and Recurrence Rate;

Primary

MeasureTime frame
28- and 60-day mortality rates;Pathogen clearance rate, blood culture conversion rate, pathogen dPCR copy number content;Mechanical ventilation duration and ICU length of stay;ICU and in-hospital mortality;

Countries

China

Contacts

Public ContactSun Renhua

Zhejiang Provincial People's Hospital

jqin168@hotmail.com+86 135 0571 0366

Outcome results

None listed

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