Postoperative InfectionNCT05187871
Study for Rapid Diagnosis of Postoperative Abdominal Infection
An observational study of Postoperative Infection and Abdominal Surgery, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective and exploratory study, which utilizes non-targeted metagenomic next-generation sequencing (mNGS) detecting drain fluid from patients who are suspected of postoperative abdominal infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Infection, Abdominal Surgery, Intra-abdominal Infection
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2021to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receive abdominal surgery including pancreatic, gastrointestinal, biliary surgery, etc. with routinely placing abdominal drainage in Peking Union Medical College Hospital. They are clinically suspected with postoperative abdominal infection.
Who may be able to join
- Patients who receive abdominal operations with routinely abdominal drainage placement.
- Abdominal infection is suspected by the clinicians, and one of the following conditions is met:
- Temperature ≥38℃;
- One of the following laboratory indicators: WBC≥10×10^9/L, PCT≥0.5ng/ml, hsCRP≥100mg/L.
Who cannot join
- Patients who are diagnosed with the abdominal infection before surgery.
- Evidence of non-abdominal infection is clear and could explain the clinical symptoms.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Establishment and Research for Rapid Diagnosis of Postoperative Abdominal Infection Based on Metagenomic Sequencing
This is a prospective and exploratory study, which utilizes non-targeted metagenomic next-generation sequencing (mNGS) detecting drain fluid from patients who are suspected of postoperative abdominal infection. This study aims to explore the clinical value of mNGS in the rapid diagnosis of postoperative abdominal infection, to refine the pathogenic bacteria spectrum, and to establish a novel procedure for postoperative abdominal infection diagnosis.
- Conditions
- Postoperative Infection, Abdominal Surgery, Intra-abdominal Infection, Postoperative Fever
- Medical subject headings
- Intraabdominal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathogenic spectrum of postoperative abdominal infection
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Consistency between mNGS and conventional culture methods
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Aug 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187871
- Sponsor's protocol ID
- SRDPAI
- Status last verified
- Nov 2021
- First submitted
- 8 Dec 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu R, Hong X, Zhang D, Xiao Y, Xu Q, Wu B, Guo J, Han X, Yang Q, Zhao Y, Wu W. Application of metagenomic sequencing of drainage fluid in rapid and accurate diagnosis of postoperative intra-abdominal infection: a diagnostic study. Int J Surg. 2023 Sep 1;109(9):2624-2630. doi: 10.1097/JS9.0000000000000500.
PubMed 37288562
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Research for Rapid Diagnosis of Postoperative Abdominal Infection Based on Metagenomic Sequencing
- ClinicalTrials.gov ID
- NCT05187871
- Acronym / sponsor ID
- SRDPAI
- Conditions
- Postoperative Infection, Abdominal Surgery, Intra-abdominal Infection, Postoperative Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 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.
This is a prospective and exploratory study, which utilizes non-targeted metagenomic next-generation sequencing (mNGS) detecting drain fluid from patients who are suspected of postoperative abdominal infection. This study aims to explore the clinical value of mNGS in the rapid diagnosis of postoperative abdominal infection, to refine the pathogenic bacteria spectrum, and to establish a novel procedure for postoperative abdominal infection diagnosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receive abdominal surgery including pancreatic, gastrointestinal, biliary surgery, etc. with routinely placing abdominal drainage in Peking Union Medical College Hospital. They are clinically suspected with postoperative abdominal infection.
Key inclusion criteria (4 listed)
- Patients who receive abdominal operations with routinely abdominal drainage placement.
- Abdominal infection is suspected by the clinicians, and one of the following conditions is met:
Key exclusion criteria (2 listed)
- Patients who are diagnosed with the abdominal infection before surgery.
- Evidence of non-abdominal infection is clear and could explain the clinical symptoms.
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 pathogenic spectrum of postoperative abdominal infection
Time frame: Through study completion, an average of 1 year
1 secondary outcome
Consistency between mNGS and conventional culture methods
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Derived from this study: PubMed 37288562Zhu R, Hong X, Zhang D, Xiao Y, Xu Q, Wu B, Guo J, Han X, Yang Q, Zhao Y, Wu W. Application of metagenomic sequencing of drainage fluid in rapid and accurate diagnosis of postoperative intra-abdominal infection: a diagnostic study. Int J Surg. 2023 Sep 1;109(9):2624-2630. doi: 10.1097/JS9.0000000000000500.
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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 Postoperative Infection and Abdominal Surgery, run by Peking Union Medical College 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 4 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 15 Sep 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?
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 pathogenic spectrum of postoperative abdominal infection (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05187871, which also lists 1 linked publication.
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 15 Sep 2022.