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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06636890
Enrollment
200
Registered
2024-10-15
Start date
2024-12-01
Completion date
2026-05-31
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbapenem-Resistant Enterobacteriaceae, Lower Respiratory Tract Infections

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.

Interventions

None listed

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The detection of the carbapenemase gene types produced by Klebsiella pneumoniae in rectal swabs and BALF by Xpert Carba-RUp to 2 weeks after each enrollmentThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026