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Enrolling by invitation NCT06636890

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

Observational Carbapenem-Resistant Enterobacteriaceae Lower Respiratory Tract Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Carbapenem-Resistant Enterobacteriaceae, Lower Respiratory Tract Infections. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • he First Affiliated Hospital of Nanjing Medical University — Nanjing

Identifiers

NCT: NCT06636890 · 2024-SR-697

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗