Intra Abdominal Infections, Peritonitis Infectious
Conditions
Keywords
multiplex pcr, microbiological investigation, intra-abdominal infection
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.
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.
Interventions
None listed
Sponsors
University of Göttingen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to availability of multiplex PCR result (in days) | Up to 1 day post-sampling | Time from intraoperative peritoneal fluid sampling to availability of the multiplex PCR result (reported in days) |
| Time to availability of conventional microbiological culture result (in days) | Up to 7 days post-sampling | Time from intraoperative peritoneal fluid sampling to availability of the final conventional microbiological culture report (reported in days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of pathogen detection between multiplex PCR and conventional culture | 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 |
Countries
Germany
Outcome results
None listed