Comparison of stool samples and rectal swabs with and without pre-enrichment for the detection of third-generation cephalosporin-resistant Enterobacterales (3GCREB)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00022520

Enrollment

478

Registered

2020-07-24

Start date

2020-08-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

U81

Interventions

Group 1: From February to April 2016, 478 stool samples that were sent to the Institute for Medical Microbiology, Immunology and Hygiene for diagnosis on 3GCREB were integrated into the study. The sto

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All submitted stool samples

Exclusion criteria

Exclusion criteria: non

Design outcomes

Primary

Measure	Time frame
The 4 screening methods are compared. The aim is to find the most effective screening with the best possible sensitivity and specificity. After the screening methods have been analyzed, this comparison can be carried out. The sensitivities, specificities, positive prediction values ??and negative prediction values ??for the individual algorithms are calculated in detail. A combined gold standard from all four algorithms is required for the calculation. For the analysis, the sensitivities of the algorithms are compared with a statistical test (for example, the McNemar test is suitable). The significance of the respective comparisons is then calculated.	—

Measure

Time frame

The 4 screening methods are compared. The aim is to find the most effective screening with the best possible sensitivity and specificity. After the screening methods have been analyzed, this comparison can be carried out. The sensitivities, specificities, positive prediction values ??and negative prediction values ??for the individual algorithms are calculated in detail. A combined gold standard from all four algorithms is required for the calculation. For the analysis, the sensitivities of the algorithms are compared with a statistical test (for example, the McNemar test is suitable). The significance of the respective comparisons is then calculated.

—

Secondary

Measure	Time frame
The secondary endpoint is comparison of the germ and patient characteristics in the different algorithms and combined algorithms. The sequencing data collected is evaluated on the PC after completion of the laboratory work. To do this, the sequences are first examined, checked for quality and any sequencing errors are corrected. Subsequently, the (possibly optimized) sequences are compared with existing sequences that are stored in databases (BLAST). By comparing it with the existing literature, narrow spectrum can be distinguished from broad spectrum ß-lactamases. In a second step, the phenotypically and genotypically collected data are then viewed, processed, compiled and supplemented with the clinical data so that a statistical evaluation can then be carried out. In addition to working out the differences between the four algorithms tested (and possibly combinations of algorithms) for the detection of 3GCREB in stool samples and rectal smears, the focus is on evaluating the distribution of the phenotypically and genotypically determined resistance mechanisms.	—

Measure

Time frame

The secondary endpoint is comparison of the germ and patient characteristics in the different algorithms and combined algorithms. The sequencing data collected is evaluated on the PC after completion of the laboratory work. To do this, the sequences are first examined, checked for quality and any sequencing errors are corrected. Subsequently, the (possibly optimized) sequences are compared with existing sequences that are stored in databases (BLAST). By comparing it with the existing literature, narrow spectrum can be distinguished from broad spectrum ß-lactamases. In a second step, the phenotypically and genotypically collected data are then viewed, processed, compiled and supplemented with the clinical data so that a statistical evaluation can then be carried out. In addition to working out the differences between the four algorithms tested (and possibly combinations of algorithms) for the detection of 3GCREB in stool samples and rectal smears, the focus is on evaluating the distribution of the phenotypically and genotypically determined resistance mechanisms.

—

Countries

Germany

Contacts

Public ContactTarek Jazmati

Institut für Medizinische Mikrobiologie, Immunologie und HygieneUniversitätsklinikum Köln

tarekjazmati@gmx.de+4915777913468

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 15, 2026