Intra Abdominal InfectionsNCT07562204
Rapid Identification of Microbial Pathogens in Intra-abdominal Infections Using Multiplex PCR
An observational study of Intra Abdominal Infections and Peritonitis Infectious, run by University of Göttingen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra Abdominal Infections, Peritonitis Infectious
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- suspected hollow organ perforation
- suspected peritonitis
- patient underwent surgical treatment
- microbiological testing of intra-abdominal fluid was needed
Who cannot join
- patient in moribund conditions
- patient already enrolled in an interventional clinical trial
- patient under 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Intra Abdominal Infections, Peritonitis Infectious
- Keywords
- multiplex pcr, microbiological investigation, intra-abdominal infection
- Medical subject headings
- Intraabdominal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Up to 7 days post-sampling
Secondary outcomes (1)
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
Measured: Perioperative (up to 7 days post-sampling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jun 2018
- Primary completion1 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra Abdominal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. T. Perl, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562204
- Sponsor's protocol ID
- 1/7/06 - 4
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buckner J, Gross U, Kunze-Szikszay N, Ghadimi M, Meissner K, Moerer O, Perl T. Rapid identification of microbial pathogens in intra-abdominal infections using multiplex PCR. Front Cell Infect Microbiol. 2026 Jul 22;16:1879793. doi: 10.3389/fcimb.2026.1879793. eCollection 2026.
PubMed 42558741
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Identification of Microbial Pathogens in Intra-abdominal Infections Using Multiplex PCR
- ClinicalTrials.gov ID
- NCT07562204
- Acronym / sponsor ID
- 1/7/06 - 4
- Conditions
- Intra Abdominal Infections, Peritonitis Infectious
- Keywords
- multiplex pcr, microbiological investigation, intra-abdominal infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- suspected hollow organ perforation
- suspected peritonitis
- patient underwent surgical treatment
- microbiological testing of intra-abdominal fluid was needed
Key exclusion criteria (3 listed)
- patient in moribund conditions
- patient already enrolled in an interventional clinical trial
- patient under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
1 secondary outcome
Concordance of pathogen detection between multiplex PCR and conventional culture
Time frame: Perioperative (up to 7 days post-sampling)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42558741Buckner J, Gross U, Kunze-Szikszay N, Ghadimi M, Meissner K, Moerer O, Perl T. Rapid identification of microbial pathogens in intra-abdominal infections using multiplex PCR. Front Cell Infect Microbiol. 2026 Jul 22;16:1879793. doi: 10.3389/fcimb.2026.1879793. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra Abdominal Infections and Peritonitis Infectious, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to availability of multiplex PCR result (in days) (time frame: Up to 1 day post-sampling). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07562204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.