Integrating Plasma Metagenomics and Host Response for Accurate Diagnosis of Infected Pancreatic Necrosis in a Prospective Multicenter Cohort of Acute Necrotizing Pancreatitis (PROMOTE)

January 6, 2026 updated by: Xiangya Hospital of Central South University
This study is being done to find a faster and more accurate way to tell whether the necrosis in patients with acute necrotizing pancreatitis (ANP) has become infected. In the absence of microbiological confirmation, clinicians often have to initiate empirical antibiotic therapy for suspected pancreatic infection-a practice supported by current guidelines but one that may contribute to antimicrobial resistance. In this study, the investigators will combine metagenomic next-generation sequencing (mNGS) which could improve the accuracy of infected pancreatic necrosis (IPN) diagnosis and host transcriptional response analysis which could discriminate infectious and noninfectious inflammatory syndromes. In a prospective, multicentre, cohort study, 200 consecutive patients ≥ 14 years with ANP will be enrolled at four tertiary hospitals from Novemeber 2025 to December 2026. If validated, this single-blood approach could enable early, pathogen-directed therapy, curtail unnecessary antibiotics and expedite surgical timing in ANP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute necrotizing pancreatitis from Xiangya Hospital Central South University, Affiliated Hospital of Guizhou Medical University, Liuzhou People's Hospital, Hunan University of Medicine General Hospital.

Description

Inclusion Criteria:

  1. Confirmed acute necrotizing pancreatitis (Revised Atlanta 2012) within 48 h of symptom onset
  2. Age ≥14 years
  3. Written informed consent

Exclusion Criteria:

  1. Invasive interventions including percutaneous catheter drainage (PCD) and surgical necrosectomy have already been performed prior to admission.
  2. Confirmed infection outside of pancreas, including pulmonary infection, urinary tract infection.
  3. Pregnancy .
  4. Acute recurrent pancreatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
definite IPN group
A positive culture of pancreatic or peripancreatic necrotic tissue obtained from the first drainage procedure or operation, or the presence of gas in the fluid collection on contrast-enhanced CT.
definite SPN group
The same specimen remained sterile after standard aerobic, anaerobic, and fungal culture.
suspected IPN group
(i) Infectious manifestations occurred during hospitalization, but such manifestations could be cured with antibiotics alone without the need of any surgical intervention (ii) Infectious manifestations emerged during the disease course, and definitive indications for surgical intervention were identified; nonetheless, surgical intervention was not performed during hospitalization, which was attributed to factors including the patient's demise; (iii) No infectious signs emerged during the disease course, but the patient died of massive hemorrhage or multiple organ failure before any invasive procedure could be performed.
clinical sterile pancreatic necrosis(SPN) group
Clinically stable during hospitalization with no intervention indicated and the blinded reviewers, after exhaustive chart review, identified no objective evidence of pancreatic infection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Diagnostic accuracy of the integrated mNGS and host-transcription model for identification of IPN.
Time Frame: through study completion, an average of 2 months
through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiangya Hospital of Central South University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Affiliated Hospital Of Guizhou Medical University
LiuZhou People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025040636

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