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RecruitingNCT06791889Updated Mar 17, 2025

Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study

An observational study in Sepsis, Bloodstream Infections and Critically Ill Intensive Care Unit Patients, sponsored by Wuhan Union Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Wuhan Union Hospital, China · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the efficacy of droplet digital PCR (ddPCR) in identifying pathogenic organisms in ICU sepsis patients, aiming to find a method that allows early identification of pathogenic organisms and dynamic surveillance in order to assess the association between pathogenic species and loads and clinical characteristics and outcomes.

Read the detailed description

This is a monocentric observational study. Patients admitted to the ICU with a first diagnosis of sepsis will be dynamically monitored for nucleic acid loads of pathogenic bacteria in the blood using ddPCR at different time points until the last blood sample is taken on day 28-30 or the patient is discharged from the ICU.

02

Conditions studied

  • Sepsis
  • Bloodstream Infections
  • Critically Ill Intensive Care Unit Patients

Keywords

  • ddPCR
  • Sepsis
  • ICU
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 60 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to ICU

Inclusion criteria

  • Patients with first diagnosis of sepsis after ICU admission

Exclusion criteria

Exclusion Criteria:

  • Age under 18 years
  • Do not meet Sepsis 3.0 diagnostic criteria
  • Refusal to sign informed consent
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • ddPCR group
06

What researchers measure

Primary outcomes

  1. Nucleic acid load of pathogenic bacteria at different time points

    Time frame: ''Nucleic acid load of pathogenic bacteria in the blood versus time'' could have a time frame of ''0, 2-3, 4-5, 6-7, 8-9, 10-12, 13-15, 20-22, 28-30 days post admission to the ICU with the first diagnosis of sepsis''.

Secondary outcomes

  1. 28-day mortality

    Time frame: Survival status at 28 days after the first diagnosis of sepsis on admission to the ICU

07

Study locations

1 of 1 sites recruiting
  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, China
    • Xiaobo Yang · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06791889
Lead sponsor
Wuhan Union Hospital, China
Responsible party
Sponsor
First posted
Jan 24, 2025
Start date
Sep 15, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Mar 17, 2025

Study contacts

You Shang, prof.
Contact
you_shanghust@163.com
008602785351606
Xiaobo Yang, prof.
Contact
want.tofly@aliyun.com
008602785351607

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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