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Species-specific Bacterial Detector for Fast Pathogen Diagnosis of Severe Pneumonia

NCT05143593 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2024-10-26

No results posted yet for this study

Summary

This study is a multicenter randomized controlled trial. The purpose of this study is to assess the efficacy of Species-specific Bacterial Dector（SSBD）for fast pathogen diagnosis and treatment in patients with severe pneumonia. Several adult ICU units from the hospitals in Jiangsu province participate the study and the hosted unit is the Department of Critical Care Medicine, Affiliated Drum Tower Hospital of Nanjing University Medical College. All patients who met the inclusion criteria are enrolled and randomly assigned either to the experiment group or to the control group, and received empiral antibiotics initially. In the experiment group, secretions from low respiratory tract are detected by SSBD and conventional culture tests simultaneously on day1,day3 and day7 after enrollment, while in the control group conventional culture tests are carried out on the same days. In the experiment group, antibiotics adjustments are made by two experienced doctors immediately when SSBD results are available, and other treatments are equivalent to those in the control group as routinely. Some clinical parameters and outcomes are recorded.

Conditions

  • Severe Pneumonia

Interventions

DIAGNOSTIC_TEST

results of SSBD are used to guide antibiotics adjustment

secretions from low resipratory will be obtained on day1,day 3 and day7 after enrollment and detected by SSBD at bedside at once. Antibiotics will be adjusted on the results by experienced doctors.

Sponsors & Collaborators

  • Chinese Medical Association

    lead NETWORK

Principal Investigators

  • Wenkui Yu, MD · The Affliated Drum Tower Hospital, Medical School of Nanjing University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05143593 on ClinicalTrials.gov