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

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.

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Key information

Conditions

Carbapenem-Resistant Enterobacteriaceae Lower Respiratory Tract Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

he First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 21000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Oct 15, 2024
Registry last updated: Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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