Liver AbscessNCT05521139
Risk Factors for Pyogenic Liver Abscess With Carbapenem-resistant Klebsiella Pneumoniae: A Matched Case-control Study
An observational study of Liver Abscess, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Pyogenic liver abscess (PLA) is a complication of infectious disease, and the most common pathogen of PLA is Klebsiella pneumoniae, while PLA caused by Carbapenem-resistant Klebsiella pneumoniae (CRKP) has become a threat to public health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Abscess
- What is being tested?
- drug sensitivity results
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 years of age or older and at least one positive culture reported by the clinical microbiology laboratory for CRKP or CSKP during the hospital length of stay. Klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results.
Who may be able to join
- 18 years of age or older. at least one positive culture reported by the clinical microbiology laboratory for CRKP or CSKP during the hospital length of stay.
- Klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results.
Who cannot join
- Less than 18 years old. patients with missing data without a drug sensitivity results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Matched Case-control Study of Carbapenem Resistant and Carbapenem Sensitive Klebsiella Pneumoniae Infected Pyogenic Liver Abscess
Pyogenic liver abscess (PLA) is a complication of infectious disease, and the most common pathogen of PLA is Klebsiella pneumoniae, while PLA caused by Carbapenem-resistant Klebsiella pneumoniae (CRKP) has become a threat to public health. For achieving a better therapeutic outcome of CRKP related PLA, it is very important to figure out the basic characteristics and risk factors of CRKP-PLA.
A retrospective cohort study was performed in which 15 PLA patients carriage of K pneumoniae were screened at the Xiangya hospital of central south university (changsha, China). The colonization and clinical infection isolates were analyzed by antimicrobial susceptibility testing to identify CRKP. All admission patients diagnosed with PLA who developed CRKP were included, 5 adults PLA patients with CRKP infected and 10 adults PLA patients with Carbapenem sensitive Klebsiella pneumoniae (CSKP) infected were conducted. Univariate and multivariate logistic regression was carried out using a stepwise selection method to compare prognostic factors between CRKP and CSKP groups.
- Conditions
- Liver Abscess
- Being tested
- drug sensitivity results
- Medical subject headings
- Liver Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug sensitivity resultsDiagnostic test
drug sensitivity results including the carbapenem-resistant Klebsiella pneumoniae and carbapenem-sensitive Klebsiella pneumoniae
| Study group | Role | What they receive |
|---|---|---|
| CRKP-PLA | Klebsiella pneumoniae were isolated from pyogenic liver abscess patients' blood or pus and the antibiotic drug sensitivity results shows it is carbapenem-resistant Klebsiella pneumoniae. Receives: Diagnostic Test: drug sensitivity results | |
| CSKP-PLA | Klebsiella pneumoniae were isolated from pyogenic liver abscess patients' blood or pus and the antibiotic drug sensitivity results shows it is carbapenem-sensitive Klebsiella pneumoniae. Receives: Diagnostic Test: drug sensitivity results |
What is being measured
The primary outcome is the main question the study is designed to answer.
the survival rates
Measured: 2monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver AbscessStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521139
- Sponsor's protocol ID
- 202005055
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Matched Case-control Study of Carbapenem Resistant and Carbapenem Sensitive Klebsiella Pneumoniae Infected Pyogenic Liver Abscess
- ClinicalTrials.gov ID
- NCT05521139
- Acronym / sponsor ID
- 202005055
- Conditions
- Liver Abscess
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 30 Aug 2022 (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.
Pyogenic liver abscess (PLA) is a complication of infectious disease, and the most common pathogen of PLA is Klebsiella pneumoniae, while PLA caused by Carbapenem-resistant Klebsiella pneumoniae (CRKP) has become a threat to public health. For achieving a better therapeutic outcome of CRKP related PLA, it is very important to figure out the basic characteristics and risk factors of CRKP-PLA.
A retrospective cohort study was performed in which 15 PLA patients carriage of K pneumoniae were screened at the Xiangya hospital of central south university (changsha, China). The colonization and clinical infection isolates were analyzed by antimicrobial susceptibility testing to identify CRKP. All admission patients diagnosed with PLA who developed CRKP were included, 5 adults PLA patients with CRKP infected and 10 adults PLA patients with Carbapenem sensitive Klebsiella pneumoniae (CSKP) infected were conducted. Univariate and multivariate logistic regression was carried out using a stepwise selection method to compare prognostic factors between CRKP and CSKP groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRKP-PLA | – | Diagnostic Test: drug sensitivity resultsKlebsiella pneumoniae were isolated from pyogenic liver abscess patients' blood or pus and the antibiotic drug sensitivity results shows it is carbapenem-resistant Klebsiella pneumoniae. |
| CSKP-PLA | – | Diagnostic Test: drug sensitivity resultsKlebsiella pneumoniae were isolated from pyogenic liver abscess patients' blood or pus and the antibiotic drug sensitivity results shows it is carbapenem-sensitive Klebsiella pneumoniae. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years of age or older and at least one positive culture reported by the clinical microbiology laboratory for CRKP or CSKP during the hospital length of stay. Klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results.
Key inclusion criteria (2 listed)
- 18 years of age or older. at least one positive culture reported by the clinical microbiology laboratory for CRKP or CSKP during the hospital length of stay.
- Klebsiella pneumoniae were isolated and identified in the blood or pus with antibiotic drug sensitivity results.
Key exclusion criteria (1 listed)
- Less than 18 years old. patients with missing data without a drug sensitivity results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug sensitivity resultsdrug sensitivity results including the carbapenem-resistant Klebsiella pneumoniae and carbapenem-sensitive Klebsiella pneumoniae | Diagnostic test | CRKP-PLA, CSKP-PLA |
Primary outcome
the survival rates
Time frame: 2monthes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Liver Abscess, run by Xiangya Hospital of Central South 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 survival rates (time frame: 2monthes). 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 30 Aug 2022.