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NOT YET RECRUITING
NCT05143593
NA

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

Sponsor: Chinese Medical Association

View on ClinicalTrials.gov

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.

Official title: Species-specific Bacterial Detector for Fast Pathogen Diagnosis of Severe Pneumonia Patients in Intensive Care Uint: a Multicentre, Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2024-11-01

Completion Date

2025-06-30

Last Updated

2024-10-26

Healthy Volunteers

No

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.

Locations (6)

Nanjing First Hospital

Nanjing, Jiangsu, China

The Affliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Nanjin Drum Tower Hospital Group Suqian Hospital

Suqian, Jiangsu, China

Changshu No.1 People's Hospital

Suzhou, Jiangsu, China

Taizhou People's Hospital

Taizhou, Jiangsu, China

Yixin People's Hospital

Wuxi, Jiangsu, China