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NCT Number: NCT07308600

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

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy of the integrated mNGS and host-transcription model for identification of IPN.

    Time frame: through study completion, an average of 2 months

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Collaborators

  • LiuZhou People's Hospital
  • The Affiliated Hospital Of Guizhou Medical University

Registry information

Acronym: PROMOTE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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