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

Influence of antibiotic treatment on the normal flora and the presence of resistance genes in known carriers of ESBL and VRE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000244-10-SE

Enrollment

Registered

2019-10-31

Start date

2019-12-13

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

Carriage of genes coding for vancomycin resistant enterococci (VRE) and extended spectrum betalactamase producing enterobacteriales (EPE) phenotypes.

Interventions

Trade Name: Ciprofloxacin Ranbaxy Product Name: Ciprofloxacin Ranbaxy Pharmaceutical Form: Tablet Trade Name: Vancomycin Xellia Product Name: Vancomycin Xellia Pharmaceutical Form: Capsule

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 168 µmol/l

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether carriage of resistant bacteria that is not detectable by conventional methods can be detected by a new metagenomic method. Also, assessing out whether carriage can be provoked by antibiotic treatment ;Secondary Objective: To assess changes in intestinal the flora that occurs in carriers of resistant intestinal bacteria when treated with antibiotics;Primary end point(s): The trial has two primary endpoints: - 1 a) Patients who switch from negative to positive in faecal tests for VRE / ESBL before versus immediately after antibiotic provocation. - 1 b) Difference in the composition, diversity and profile of the intestinal flora, before compared to directly after antibiotic provocation.;Timepoint(s) of evaluation of this end point: Directly after antibiotic treatment	—

Measure

Time frame

Main Objective: To assess whether carriage of resistant bacteria that is not detectable by conventional methods can be detected by a new metagenomic method. Also, assessing out whether carriage can be provoked by antibiotic treatment ;Secondary Objective: To assess changes in intestinal the flora that occurs in carriers of resistant intestinal bacteria when treated with antibiotics;Primary end point(s): The trial has two primary endpoints: - 1 a) Patients who switch from negative to positive in faecal tests for VRE / ESBL before versus immediately after antibiotic provocation. - 1 b) Difference in the composition, diversity and profile of the intestinal flora, before compared to directly after antibiotic provocation.;Timepoint(s) of evaluation of this end point: Directly after antibiotic treatment

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Secondary

Measure	Time frame
Secondary end point(s): The trial has three secondary endpoints 2 (a) Time until participants, who switched to positive VRE / ESBL test during antibiotic treatment, besome negative again - 2 b) Time until the composition, diversity and profile of the intestinal flora return to baseline. - 2 c) Difference in sensitivity with respect to detection of resistance genes of conventional compared to metagenomic method defined as discordant results.;Timepoint(s) of evaluation of this end point: 2 a) After first negative test 2 b) After one year 2 c) Before and up to one year after antibiotic treatment	—

Measure

Time frame

Secondary end point(s): The trial has three secondary endpoints 2 (a) Time until participants, who switched to positive VRE / ESBL test during antibiotic treatment, besome negative again - 2 b) Time until the composition, diversity and profile of the intestinal flora return to baseline. - 2 c) Difference in sensitivity with respect to detection of resistance genes of conventional compared to metagenomic method defined as discordant results.;Timepoint(s) of evaluation of this end point: 2 a) After first negative test 2 b) After one year 2 c) Before and up to one year after antibiotic treatment

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Countries

Sweden

Contacts

Public ContactInfektionsmottagningen

Region Uppsala

+46186110000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026