Liver Abscess, PyogenicNCT05213949
An Observational Study of Risk Factors and Long-term Prognosis of Patients With Liver Abscess in the "Real-world"
An observational study of Liver Abscess, Pyogenic and Liver Abscess, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Pyogenic liver abscess is one of the most common visceral abscesses, its incidence is increasing worldwide. According to the previous literature, the mortality rate of pyogenic liver abscess is as high as 31% and become a serious social health problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Abscess, Pyogenic, Liver Abscess, Abscess
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2025
- 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 older than 18 years of age admitted for pyogenic liver abscesses
Who may be able to join
- Patients older than 18 years of age;
- Irrespective of gender;
- Symptomatic patients of liver abscess confirmed with radiology imaging, either by ultrasonography or computed tomography scan.
Who cannot join
- Patients <18 years old;
- Pregnancy at presentation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 5100515
Xuyen M University, MD, 02062786539, xuxuwen95@126.com
About this study
Official title: An Observational Study of Risk Factors and Long-term Prognosis of Patients With Pyogenic Liver Abscess in the "Real-world"
Pyogenic liver abscess is one of the most common visceral abscesses, its incidence is increasing worldwide. According to the previous literature, the mortality rate of pyogenic liver abscess is as high as 31% and become a serious social health problem. However, the data of prospective observational real-world studies are scarce and no relevant research of the liver histological change has been reported, so the long-term prognosis and the risk factors for pyogenic liver abscess are still unknown. Patients will be followed up prospectively for a period of 2 years and observed clinical prognosis (all-cause mortality, the recurrence rate, and the rehospitalization rate). The investigators will investigate the predictive value of clinical risk factors for clinical prognosis and establish clinical prediction models to predict the long-term prognosis of pyogenic liver abscesses.
- Conditions
- Liver Abscess, Pyogenic, Liver Abscess, Abscess, Infections
- Keywords
- Pyogenic Liver abscess, Liver histological change
- Medical subject headings
- Liver Abscess, Pyogenic, Liver Abscess, Abscess, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion and causes of deaths within 2 years of discharge from hospital
Define the proportion and causes of deaths within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses.
Measured: 2 years
Proportion and causes of re-hospitalization within 2 years of discharge from hospital
Define the proportion and causes of re-hospitalization within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses.
Measured: 2 years
Secondary outcomes (2)
The recurrence rate of pyogenic liver abscess
Development new liver abscess after clinical cure during the 2 years follow up period
Measured: 2 years
The number of participants with Histological Change in the Liver
Assessment of histological change in the liver by using ultrasonography or transient elastography during the 2 years follow up period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Abscess, PyogenicStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213949
- Sponsor's protocol ID
- NFEC-2021-355
- Status last verified
- Aug 2022
- First submitted
- 30 Dec 2021
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers except for those are directly involved with this study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Risk Factors and Long-term Prognosis of Patients With Pyogenic Liver Abscess in the "Real-world"
- ClinicalTrials.gov ID
- NCT05213949
- Acronym / sponsor ID
- NFEC-2021-355
- Conditions
- Liver Abscess, Pyogenic, Liver Abscess, Abscess, Infections
- Keywords
- Pyogenic Liver abscess, Liver histological change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 28 Jan 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 is one of the most common visceral abscesses, its incidence is increasing worldwide. According to the previous literature, the mortality rate of pyogenic liver abscess is as high as 31% and become a serious social health problem. However, the data of prospective observational real-world studies are scarce and no relevant research of the liver histological change has been reported, so the long-term prognosis and the risk factors for pyogenic liver abscess are still unknown. Patients will be followed up prospectively for a period of 2 years and observed clinical prognosis (all-cause mortality, the recurrence rate, and the rehospitalization rate). The investigators will investigate the predictive value of clinical risk factors for clinical prognosis and establish clinical prediction models to predict the long-term prognosis of pyogenic liver abscesses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years of age admitted for pyogenic liver abscesses
Key inclusion criteria (3 listed)
- Patients older than 18 years of age;
- Irrespective of gender;
- Symptomatic patients of liver abscess confirmed with radiology imaging, either by ultrasonography or computed tomography scan.
Key exclusion criteria (2 listed)
- Patients <18 years old;
- Pregnancy at presentation.
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
Proportion and causes of deaths within 2 years of discharge from hospital
Time frame: 2 years
Define the proportion and causes of deaths within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses.
Proportion and causes of re-hospitalization within 2 years of discharge from hospital
Time frame: 2 years
Define the proportion and causes of re-hospitalization within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses.
2 secondary outcomes
The recurrence rate of pyogenic liver abscess
Time frame: 2 years
The number of participants with Histological Change in the Liver
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers except for those are directly involved with this study.
Related trials for Liver Abscess, Pyogenic
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Liver Abscess, Pyogenic
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.
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, Pyogenic and Liver Abscess, run by Nanfang Hospital, Southern 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: status not confirmed, as of the sponsor's last update on 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuyen Xu, MD (020-62786539, xuxuwen95@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion and causes of deaths within 2 years of discharge from hospital (time frame: 2 years). 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 8 Aug 2022.