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

NCT07562204 | Completed

• 1 other identifier: 1/7/06 - 4
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intra Abdominal Infections; Peritonitis Infectious

Keywords

multiplex pcr; microbiological investigation; intra-abdominal infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Concordance of pathogen detection between multiplex PCR and conventional culture

  Perioperative (up to 7 days post-sampling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Göttingen: lead

Study Sites (1)

University Medical Center Göttingen

Göttingen, 37075, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

intra-abdominal peritoneal fluid samples

MeSH Terms

Conditions

Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: May 1, 2026
• Study Start: June 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2020
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

DE (1)