Comparison between certified swab systems (Copan eSwabTM) and commercially available cotton swabs (Q-Tip) for the detection of multi-resistant pathogens (MRE) using rectal swabs

• Conditions: U80; U81

• Registration Number: DRKS00023249
• Lead Sponsor: niversität Leipzig, Klinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie und Infektiologie Bereich Hepatologie

Brief Summary

Results: A total of 196 swab pairs were collected from 164 participants. MDRB were detected in 36 of 164 cases (22%). There were neither false-negative nor false-positive results using commercial cotton swabs. In 8 of 196 samples (4.1%) MDRB species were detected only by using cotton swabs, including vancomycin-resistant Enterococcus faecium, OXA-48 producing Escherichia coli, ESBL-producing Klebsiella pneumoniae and ESBL-producing Escherichia coli. Discussion: Commercial cotton swabs turned out to be a reliable alternative to Copan eSwabs. For practical use as a screening tool, relevant storage- and manufacturer-related contamination must be ruled out beforehand. Conclusions: Commonly available double-tipped cotton swabs can be used for rectal MDRB screening in the event of supply shortages of certified swabs. Further studies should clarify their suitability as a sampling system for nasopharyngeal MRSA carriage or even for the molecular biological detection of SARS-CoV-2.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-07
• Study Completion: 2021-10-23
• Results First Posted: 2022-02-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Existence of a written declaration of consent for the smears and data processing within the scope of the study; Inpatients in the areas of gastroenterology / hepatology G03.2; Indication for the MRE rectal smear according to the checklist MRE anamnesis recording sheet, revision 008 / 06.2020, ID number 23109 of the Leipzig University Hospital

Exclusion Criteria

Patients who are under care or who are not legally competent; lack of written consent for smear collection and data processing; Patients in inpatient areas other than ward G03.2; Participation in another clinical study; known pregnancy / lactation period

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the Q-Tip smear for MRP detection

Secondary Outcome Measures

Name	Time	Method
semiquantitative MDRO detection rate