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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07308600

Acronym

PROMOTE

Enrollment

200

Registered

2025-12-29

Start date

2026-01-30

Completion date

2026-12-30

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Necrotizing Pancreatitis, Infected Pancreatic Necrosis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of the integrated mNGS and host-transcription model for identification of IPN.	through study completion, an average of 2 months

Outcome results