Correlation Analysis of Xpert Carba-R Detection of Non-colonized CRE in BALF and Rectal Swabs From Patients With LRTI

March 11, 2025 updated by: The First Affiliated Hospital with Nanjing Medical University

Correlation Analysis of Xpert Carba-R Detection of Non-Colonized Carbapenem-Resistant Enterobacteriaceae in Bronchoalveolar Lavage and Rectal Swabs From Patients With Lower Respiratory Tract Infections

Assess the correlation between Xpert Carba-R detection of carbapenemase gene types in bronchoalveolar lavage samples and rectal swab samples from non-colonized CRKP patients with lower respiratory tract infections, and evaluate the relationship between first-time lower respiratory tract infections and intestinal colonization of CRKP.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 21000
        • he First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population description specifies individuals diagnosed with LRTI (Lower Respiratory Tract Infection) who were enrolled based on culture-confirmed CRKP（Carbapenem-resistant Klebsiella pneumoniae）.

Description

Inclusion Criteria:

  • Aged 18 years and above
  • CRKP is cultured from lower respiratory tract specimens in 15 days
  • Lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°C or less than 36.5°C), leucocyte count abnormality (leucocyte count greater than 10*10^9/L or less than 4*10^9/L), and the presence of purulent tracheal secretions.

Exclusion Criteria:

  • There are other bacteria that can produce carbapenemases exist in lower respiratory tract specimens
  • Infected with CRE before

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detection of the carbapenemase gene types produced by Klebsiella pneumoniae in rectal swabs and BALF by Xpert Carba-R
Time Frame: Up to 2 weeks after each enrollment
The investigators use the Xpert Carba-R to detect the carbapenemase gene types produced by Klebsiella pneumoniae in rectal swabs and bronchoalveolar lavage fluid (BALF) . The investigators will compare the consistency of results between the two specimens.
Up to 2 weeks after each enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-SR-697

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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