Validation of methods for sequencing isolates from patients, drinking water, and wastewater to determine their epidemiological significance and regulation based on this information

Validation of methods for sequencing isolates from patients, drinking water, and wastewater to determine their epidemiological significance and regulation based on this information - VaSequIs

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038937

Enrollment

960

Registered

2026-02-12

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

nosocomial infection

Interventions

Group 1: The study includes all patients < 18 years of age whose microbiological samples contain reference pathogens. In this context, reference pathogens are defined as all isolates of: • Aeromona

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The study includes all patients < 18 years of age from whom microbiological samples containing the above-mentioned reference pathogens were obtained. In addition, trauma surgery patients < 18 years of age from whom microbiological samples were obtained from surgical wounds on the lower leg, ankle, and foot or intraoperatively from these body sites and who tested positive for Gram-negative rods and enterococci are included.

Exclusion criteria

Exclusion criteria: not available

Design outcomes

Primary

Measure	Time frame
Evidence and extent of the microbiological, molecular genetic, and epidemiological connection between clinically relevant patient isolates and isolates from drinking water and wastewater samples from Essen University Hospital (e.g., proportion of genetically matching isolate pairs, cluster formation).	—

Secondary

Measure	Time frame
Performance of the newly established high-frequency monitoring system (e.g., number/rate of detected pathogens, sequenceability, runtimes). • Spectrum and frequency of obligate/facultative pathogens and antibiotic-resistant pathogens (especially 4 MRGN, water-associated germs) in drinking water, wastewater, and patient samples. • Identified contamination and transmission routes with hygienic relevance (e.g., certain pipe sections, biofilm formation). • Formulated evidence-based recommendations for improving drinking water and wastewater hygiene and patient safety in priority facilities. • Contribution of the data to the possible further development or adaptation of regulatory requirements (e.g., risk-oriented monitoring, special requirements for priority facilities).	—

Measure

Time frame

Performance of the newly established high-frequency monitoring system (e.g., number/rate of detected pathogens, sequenceability, runtimes). • Spectrum and frequency of obligate/facultative pathogens and antibiotic-resistant pathogens (especially 4 MRGN, water-associated germs) in drinking water, wastewater, and patient samples. • Identified contamination and transmission routes with hygienic relevance (e.g., certain pipe sections, biofilm formation). • Formulated evidence-based recommendations for improving drinking water and wastewater hygiene and patient safety in priority facilities. • Contribution of the data to the possible further development or adaptation of regulatory requirements (e.g., risk-oriented monitoring, special requirements for priority facilities).

—

Countries

Germany

Contacts

Public ContactJan Buer

Uniklinikum

Jan.Buer@uk-essen.de+49201723-3500

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026