Comparison of 18S rDNA polymerase chain reaction in heart valve issue and third generation sequencing in blood for pathogen detection in patients with blood-culture negative infective endocarditis - Evaluation of diagnostic performance parameters, methodological efficiency, and the impact of antibiotic penetration in valve tissue

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037816

Enrollment

Registered

2025-09-02

Start date

2026-04-27

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I33.0

Interventions

Group 1: Patients with blood culture–negative infective endocarditis who have an indication for surgical valve repair and antibiotic therapy will be enrolled in the study after providing informed cons

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age = 18 years - Patients with confirmed infective endocarditis according to the Duke criteria, without pathogen detection by blood cultures prior to surgery - Indication for open or minimally invasive surgical valve intervention - Availability of written informed consent provided by the patient

Exclusion criteria

Exclusion criteria: - Age under 18 years - Women who are pregnant or breastfeeding - Active participation in a clinical trial under the German Medicinal Products Act (AMG) or the Medical Device Law (MPDG) on the day of surgery

Design outcomes

Primary

Measure	Time frame
Proportion of positive pathogen detections using PCR technology vs. TGS method from intraoperatively excised valve tissue and from plasma	—

Secondary

Measure	Time frame
1) Calculation of sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy of the PCR and TGS methods 2) Analysis of the methodological and cost-related advantages of the TGS method compared to the PCR method 3) Therapeutic drug monitoring (TDM) of antibiotic therapy in plasma and interstitial fluid (ISF) using microdialysis technique as part of routine clinical practice 4) Investigation of tissue penetration of antibiotic therapy into valve tissue by determining homogenate concentrations in excised valve material and comparing them with routinely measured plasma and ISF concentrations obtained through TDM 5) Investigation of a possible correlation between negative pathogen detection by PCR or TGS methods and the antibiotic concentrations determined by TDM in plasma, ISF, and the homogenate of excised valve tissue	—

Measure

Time frame

1) Calculation of sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy of the PCR and TGS methods 2) Analysis of the methodological and cost-related advantages of the TGS method compared to the PCR method 3) Therapeutic drug monitoring (TDM) of antibiotic therapy in plasma and interstitial fluid (ISF) using microdialysis technique as part of routine clinical practice 4) Investigation of tissue penetration of antibiotic therapy into valve tissue by determining homogenate concentrations in excised valve material and comparing them with routinely measured plasma and ISF concentrations obtained through TDM 5) Investigation of a possible correlation between negative pathogen detection by PCR or TGS methods and the antibiotic concentrations determined by TDM in plasma, ISF, and the homogenate of excised valve tissue

—

Countries

Germany

Contacts

Public ContactPhilipp Simon

Universitätsklinikum Augsburg

philipp.simon3@uk-augsburg.de+49 0821 400 2371

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026