Carbapenem-Resistant EnterobacteriaceaeNCT06636890
Correlation Analysis of Xpert Carba-R Detection of Non-colonized CRE in BALF and Rectal Swabs From Patients With LRTI
An observational study of Carbapenem-Resistant Enterobacteriaceae and Lower Respiratory Tract Infections, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae, Lower Respiratory Tract Infections
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 May 2026
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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）.
Who may be able to join
- 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.
Who cannot join
- There are other bacteria that can produce carbapenemases exist in lower respiratory tract specimens
- Infected with CRE before
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
he First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 21000
About this study
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
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 weeks after each enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Dec 2024
- Primary completion1 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-Resistant EnterobacteriaceaeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636890
- Sponsor's protocol ID
- 2024-SR-697
- Status last verified
- Mar 2025
- First submitted
- 7 Oct 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06636890
- Acronym / sponsor ID
- 2024-SR-697
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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）.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- There are other bacteria that can produce carbapenemases exist in lower respiratory tract specimens
- Infected with CRE before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbapenem-Resistant Enterobacteriaceae and Lower Respiratory Tract Infections, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.