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

NCT05143593 | Not Yet Recruiting

• 1 other identifier: 2021-260-04
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Diagnosis, Pathogen, Pneumonia

Outcome Measures

Primary Outcomes (1)

• Improved Acute Physiology and Chronic Health Evaluation score II score

  Acute Physiology and Chronic Health Evaluation score II score will be assessed and compared on day1, day3, day7, day10 and day14

  up to 14 days

Secondary Outcomes (2)

• the therapeutic turnaround time (TTAT)

  on day1, day3,day7

• coverage of appropriate antibiotics

  on day1, day3,day7

Study Arms (2)

the experiment group

EXPERIMENTAL

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

Diagnostic Test: results of SSBD are used to guide antibiotics adjustment

the control group

NO INTERVENTION

As routinely, antibiotics adjustmens are guided on the results of conventional culture tests and other clinical parameters by two experienced doctors.

Interventions

results of SSBD are used to guide antibiotics adjustment DIAGNOSTIC_TEST

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.

the experiment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years;
• Pneumonia with undetermined pathogen and lower respiratory tract specimens can be obtained ;
• signed informed consent;

You may not qualify if:

• Pregnant women
• Lactating women
• Those who specimens of lower respiratory tract cannot be obtained;
• The main responsibility of infection was not in the lung, but outside the lung;
• Patients have participated in other clinical studies.

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (6)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

The Affliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

Location

Nanjin Drum Tower Hospital Group Suqian Hospital

Suqian, Jiangsu, 223800, China

Location

Changshu No.1 People's Hospital

Suzhou, Jiangsu, 215500, China

Location

Taizhou People's Hospital

Taizhou, Jiangsu, 225300, China

Location

Yixin People's Hospital

Wuxi, Jiangsu, 214200, China

Location

MeSH Terms

Conditions

Pneumonia; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenkui Yu, MD

  The Affliated Drum Tower Hospital, Medical School of Nanjing University

  STUDY CHAIR

Central Study Contacts

Yan Wang, MD

CONTACT

86+025-83106666-40400; a_nengneng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 3, 2021
• Study Start: November 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)