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Completed

NCT Number: NCT07562204

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Göttingen

Göttingen, 37075, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to availability of multiplex PCR result (in days)

    Time frame: Up to 1 day post-sampling

    Time from intraoperative peritoneal fluid sampling to availability of the multiplex PCR result (reported in days)

  2. Time to availability of conventional microbiological culture result (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)

Secondary outcomes

  1. Concordance of pathogen detection between multiplex PCR and conventional culture

    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

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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