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A new protocol for rapid diagnosis of sepsis pathogenic microorganisms based on nanopore sequencing: a randomized controlled trial

A new protocol for rapid diagnosis of sepsis pathogenic microorganisms based on nanopore sequencing: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048455
Enrollment
Unknown
Registered
2021-07-09
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

Sepsis

Interventions

Group 1:Antibiotics directed by nanopore sequencing
Group 2:Empirical use of antibiotics

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Suspected sepsis patients, meet any of the following (1) plus (2)-(4): (1) Infection or suspected infection; (2) qSOFA>=2; (3) SOFA=1 ; (4) NEWS score 4-6 points. 2. Patients with sepsis: meet the clinical diagnostic criteria of sepsis or septic shock according to the 3rd edition of the International Consensus Definition of Sepsis and Septic Shock (Sepsis-3).

Exclusion criteria

Exclusion criteria: 1. Aged <18 years; 2. Suffering from autoimmune diseases, acquired immune deficiency syndrome, agranulocytosis, malignant tumors or other serious chronic diseases (heart failure, liver failure, end-stage renal disease, etc.); 3. Are receiving glucocorticoid therapy; 4. Pregnancy; 5. Refuse to join the group or give up active treatment.

Design outcomes

Primary

MeasureTime frame
28-day composite endpoint of septic shock and death;

Secondary

MeasureTime frame
Detection rate of pathogen;Duration of antibiotic treatment;Type and duration of respiratory support;Duration of vasoactive drugs;Duration of continuous renal replacement therapy (CRRT);Systemic infection-related organ failure score;Improved early warning score (MEWS);

Countries

China

Contacts

Public ContactChen Yuguo

Qilu Hospital of Shandong University

chen919085@sdu.edu.cn+86 531 82169376

Outcome results

None listed

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