An observational study in Intra Abdominal Infections and Peritonitis Infectious, sponsored by University of Göttingen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Göttingen · Observational
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.
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.
129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.
This study's enrollment of 50 is below the median of 174 across 48 observational studies indexed under Intraabdominal Infections.
Browse Intraabdominal Infections studies →University of Göttingen is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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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
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Exclusion Criteria:
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)
Time frame: 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)
Time frame: Up to 7 days post-sampling
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
Time frame: Perioperative (up to 7 days post-sampling)
Ran from Jun 2018 to primary completion in Jun 2020, 24 months.
Of 24 observational studies under Intraabdominal Infections, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 24 months is above that.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Göttingen