Rapid Identification of Microbial Pathogens in Intra-abdominal Infections Using Multiplex PCR

With this study, the investigators want to determine whether a fast identification of microorganisms causing intra-abdominal infections in patients with suspected hollow organ perforation or peritonitis is possible using a multiplex PCR system (Unyvero A50), a method that allows rapid detection of predefined bacterial and fungal targets directly from clinical samples. Therefore, intra-abdominal peritoneal fluid samples collected during surgery will be analyzed by multiplex PCR and by conventional microbiological culture. The investigators want to determine whether multiplex PCR diagnostics could provide results faster than conventional microbiological methods and deliver additional information on pathogen detection.

Study Overview

• Status: Completed
• Conditions: Peritonitis Infectious; Intra Abdominal Infections

Detailed Description

This prospective observational study evaluates a rapid multiplex PCR system (Unyvero A50, Curetis) as an adjunct to conventional microbiological culture (cMB) in adult patients undergoing surgery for suspected hollow viscus perforation or peritonitis. During surgery, two intra-abdominal peritoneal fluid samples will be collected. One sample will be processed by routine aerobic and anaerobic culture at the microbiology laboratory. The second sample will be analyzed postoperatively using multiplex PCR at the surgical intensive care unit according to the manufacturer's instructions.

The study will compare turnaround time and concordance of pathogen detection between multiplex PCR and cMB. Additional descriptive analyses will include pathogen group distributions, polymicrobial findings, and results by anatomical site of perforation. Resistance markers detected by PCR will be recorded descriptively. Invalid PCR results will be documented and excluded from paired analyses.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • Göttingen, Germany, 37075
    • University Medical Center Göttingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected hollow organ perforation at the University Medical Center Göttingen, who underwent surgical treatment and were admitted to the intensive care unit for postoperative care

Description

Inclusion Criteria:

• suspected hollow organ perforation
• suspected peritonitis
• patient underwent surgical treatment
• microbiological testing of intra-abdominal fluid was needed

Exclusion Criteria:

• patient in moribund conditions
• patient already enrolled in an interventional clinical trial
• patient under 18

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to availability of multiplex PCR result (in days)	Time from intraoperative peritoneal fluid sampling to availability of the multiplex PCR result (reported in days)	Up to 1 day post-sampling
Time to availability of conventional microbiological culture result (in days)	Time from intraoperative peritoneal fluid sampling to availability of the final conventional microbiological culture report (reported in days)	Up to 7 days post-sampling

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance of pathogen detection between multiplex PCR and conventional culture	Proportion of evaluable sample pairs with complete concordance of pathogen detection between multiplex PCR and conventional microbiological culture	Perioperative (up to 7 days post-sampling)

Collaborators and Investigators

• Sponsor: University of Göttingen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: intra-abdominal infection; microbiological investigation; multiplex pcr
• Additional Relevant MeSH Terms: Infections; Intraabdominal Infections
• Other Study ID Numbers: 1/7/06 - 4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No