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

NCT06636890 | Enrolling By Invitation

• 1 other identifier: 2024-SR-697
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carbapenem-Resistant Enterobacteriaceae; Lower Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• The detection of the carbapenemase gene types produced by Klebsiella pneumoniae in rectal swabs and BALF by Xpert Carba-R

  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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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）.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

he First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 21000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will perform bronchoscopy and collect bronchoalveolar lavage fluid (BALF) samples at the time of patient enrollment.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CN (1)