Once a carrier - always a carrier? How is the normal flora and the carriage of resistance genes affected by antibiotic treatment?

Phase 1

• Conditions: Carriage of genes coding for vancomycin resistant enterococci (VRE) and extended spectrum betalactamase producing enterobacteriales (EPE) phenotypes.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-000244-10-SE
• Lead Sponsor: Region Uppsala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-31
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

-Signed consent
-Above 18 years of age
-Verified carrier of VRE/EPE in screening or Clinical Culture
-Negative in latest screening for VRE or EPE (whichever is applicable)
-For EPE Carriers, the bacterial strain must be resistant, R, for ciprofloxacin
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

-Ongoing antibiotic treatment or antibiotic treatment in the last month
-Known allergic reaction or contraindication against ciprofloxacin (for the EPE branch)
-Known allergic reaction or contraindication against vancomycin (for the VRE branch)
-Severely reduced kidney function, defined as creatinin clearance <30 ml/min/1,73 m² or serum creatinin >168 µmol/l

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified