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

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

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

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
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

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

Xiangya Hospital of Central South University

Collaborators

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)

January 30, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Estimated)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025040636

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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