Infection, BacterialHVCRKPNCT06190548
Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection
An observational study of Infection, Bacterial, run by West China Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the risk factors of mortality for CRKP infected patients, and to compare the clinical outcomes between hvCRKP infection and cCRKP infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- How many people
- 556 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Jun 2023
- 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: Patients with CRKP infection
Who may be able to join
- Adult patients (≥18-year-old) with CRKP infections were included.
Who cannot join
- younger than 18 years old; clinical samples were identified to contain CRKP but were sentenced to be colonization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection: a Single-centre Cohort Study With Multiplex Analyses in China
The goal of this observational study is to learn about the risk factors of mortality for CRKP infected patients, and to compare the clinical outcomes between hvCRKP infection and cCRKP infection. The main question it aims to answer is • Whether hypervirulence would add value to cCRKP infection and cause worse outcomes? Participants data will be collected through medical records.
Read the detailed description
We conducted an observational cohort study comprising three-year (2019-2022) data in a Chinese university hospital. We performed genome sequencing for CRKP strains, compared adult patients infected by hvCRKP with those by non-hypervirulent "classical" CRKP (cCRKP), and used propensity score matching (PSM) for imbalanced baseline characteristics. We defined 30-day all-cause and attributed mortalities and 30-day ranking outcomes (death, no response/progress, remission) as primary outcomes and post-infection stay and survival as secondary outcomes. We constructed mortality-predicting models and performed subgroup analyses for CRKP of the dominant sequence or capsular type or with varied virulence profiles and for patients with bloodstream or lower respiratory tract infections.
- Conditions
- Infection, Bacterial
- Keywords
- Klebsiella pneumoniae, hypervirulent, clinical outcome
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cCRKP | Patients with classic CRKP infection | |
| hvCRKP | Patients with hypervirulent CRKP infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
The mortality of patients 30-days after CRKP infection
Measured: 30 days
The number of participants with status
The status of patients 30 days after CRKP infection, including death, no response or progress, and remission.
Measured: 30 days
Secondary outcomes (2)
length of stay (LOS) in the hospital
length of stay of the patients
Measured: 30 days
post-infection survival
Survival of patients after CRKP infection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jul 2019
- Primary completion1 Jul 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Retrospective
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya Hu, West China Hospital
- Investigators
- Center of infectious diseases, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190548
- Sponsor's protocol ID
- SichuanU
- Other IDs
- 81861138055
- Acronym
- HVCRKP
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The original data might be shared in the form of an article attachment, but it was not decided for now.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection: a Single-centre Cohort Study With Multiplex Analyses in China
- ClinicalTrials.gov ID
- NCT06190548
- Acronym / sponsor ID
- HVCRKP / SichuanU
- Conditions
- Infection, Bacterial
- Keywords
- Klebsiella pneumoniae, hypervirulent, clinical outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Jan 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.
The goal of this observational study is to learn about the risk factors of mortality for CRKP infected patients, and to compare the clinical outcomes between hvCRKP infection and cCRKP infection. The main question it aims to answer is • Whether hypervirulence would add value to cCRKP infection and cause worse outcomes? Participants data will be collected through medical records.
Detailed description
We conducted an observational cohort study comprising three-year (2019-2022) data in a Chinese university hospital. We performed genome sequencing for CRKP strains, compared adult patients infected by hvCRKP with those by non-hypervirulent "classical" CRKP (cCRKP), and used propensity score matching (PSM) for imbalanced baseline characteristics. We defined 30-day all-cause and attributed mortalities and 30-day ranking outcomes (death, no response/progress, remission) as primary outcomes and post-infection stay and survival as secondary outcomes. We constructed mortality-predicting models and performed subgroup analyses for CRKP of the dominant sequence or capsular type or with varied virulence profiles and for patients with bloodstream or lower respiratory tract infections.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cCRKP | – | –Patients with classic CRKP infection |
| hvCRKP | – | –Patients with hypervirulent CRKP infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CRKP infection
Key inclusion criteria (1 listed)
- Adult patients (≥18-year-old) with CRKP infections were included.
Key exclusion criteria (1 listed)
- younger than 18 years old; clinical samples were identified to contain CRKP but were sentenced to be colonization
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
30-day mortality
Time frame: 30 days
The mortality of patients 30-days after CRKP infection
The number of participants with status
Time frame: 30 days
The status of patients 30 days after CRKP infection, including death, no response or progress, and remission.
2 secondary outcomes
length of stay (LOS) in the hospital
Time frame: 30 days
post-infection survival
Time frame: 30 days
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 5 Jan 2024.
- Individual participant dataSharing planned: Undecided. The original data might be shared in the form of an article attachment, but it was not decided for now.
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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.
Center of infectious diseases study director
West China Hospital
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 Infection, Bacterial, run by West China Hospital 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 1 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 5 Jan 2024. 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?
30-day mortality (time frame: 30 days). The study lists 2 primary outcomes in all. 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 5 Jan 2024.