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Rapid microdroplet digital PCR testing methods for patients with suspected bloodstream infection: a study protocol for a multicenter, prospective, stepped cluster randomized controlled trial

Rapid microdroplet digital PCR testing methods for patients with suspected bloodstream infection: a study protocol for a multicenter, prospective, stepped cluster randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094778
Enrollment
Unknown
Registered
2024-12-27
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Bloodstream Infection

Interventions

ddPCR Group:Perform digital PCR testing and use antibiotics based on the results
Control Group:Perform standard testing and use antibiotics based on the results

Sponsors

West China Tianfu Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Over 18 years old, the patient or his / her legal agent shall sign the informed consent form on the day of enrollment; 2.Patients who were admitted to the ICU; 3. Clinical suspicion of bloodstream infection, and blood culture test, at least meet the following two points: 3.1 The highest body temperature is> 38.3?; 3.2 The increase in white blood cell count is hardly explained by non-infectious factors; 3.3 The increase in CRP / ESR / FER values is difficult to be explained by non-infectious factors; 3.4 The increase in PCT value cannot be not easily explained by non-infectious factors; 3.5 BSI risk factors: (i) advanced age (65 years) and (ii) immunosuppression. In the past few months, immunosuppressants, including glucocorticoids, or combined complications (such as tumors, especially cancer, kidney failure, liver failure, AIDS, no spleen, etc.). In addition, diabetes and obesity were considered as they may alter the immune system and increase the risk of BSI. And (iii) a previous diagnosis or a family history of immunodeficiency.(And iv) approximately 50% of intensive care patients have nosocomial infection. And (v) Invasive procedures such as mechanical ventilation and endovascular catheterization.

Exclusion criteria

Exclusion criteria: 1) The patient information is not entered into the electronic medical record system; 2) Refuse to draw blood or refuse to participate in the test; 3) Mental disorders or pregnant women; 4) Participated in other clinical trials; 5) Expected length of hospital stay is <72h.

Design outcomes

Primary

MeasureTime frame
relative change in SOFA score on day 7 or ICU discharge / death versus day 0;

Secondary

MeasureTime frame
consumption of antimicrobial agents during ICU stay (in daily dose);days from enrollment to targeted antimicrobial therapy;overall antimicrobial use and cost;total hospitalization costs;ICU, hospital stay;mortality rate of 28 and 90 days;duration of mechanical ventilation or vasoactive drug application;

Countries

China

Contacts

Public ContactXuelian Lian

West China Tianfu Hospital, Sichuan University

wowrachelwcx@gmail.com+86 189 8060 2202

Outcome results

None listed

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