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

NCT ID: NCT06636890

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carbapenem-Resistant Enterobacteriaceae Lower Respiratory Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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he First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2024-SR-697

Identifier Type: -

Identifier Source: org_study_id

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