University Medical Center Göttingen
Göttingen, 37075, Germany
NCT Number: NCT07562204
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.
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Notify Me18 year and older
All sexes
Observational
Göttingen, 37075, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 1 day post-sampling
Time from intraoperative peritoneal fluid sampling to availability of the multiplex PCR result (reported in days)
Time frame: Up to 7 days post-sampling
Time from intraoperative peritoneal fluid sampling to availability of the final conventional microbiological culture report (reported in days)
Time frame: Perioperative (up to 7 days post-sampling)
Proportion of evaluable sample pairs with complete concordance of pathogen detection between multiplex PCR and conventional microbiological culture
University of Göttingen
Other
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