CIPROFLOXACIN for VRE carriage | ESBL carriage

Inclusion criteria

• {"criterion_text":"- Signed consent, >18 years of age, Verified carriage of VRE/EPE in screening or clinical culture, Negativity in latest screening for VRE/EPE, For EPE carriers the isolate must be ressitant (R) to ciprofloxacin, Adquate contraception for fertile women (as recommended bythe CTFG)"}

Exclusion criteria

• {"criterion_text":"- Known allergy to ciprofloxacin or contraindication for ciprofloxacin treatmen (for EPE arm), kidney failure as defined by creatinin clearance < 30 ml/min/1,73 m3 or serum creatinin > 168 µmol (for EPE arm), significant interaction with ciprofloxacin (EPE arm), known allergy or contraindication for vancomycin (VRE arm), pregnancy or breastfeeding, other morbidity or condition which makes the person ineligible for inklusion"}

Primary endpoints

• {"endpoint_text":"- 1 a) Transition from negative to positive fecal screen for VRE/EPE directly after antibiotic challenge.\n- 1b) Differences in the microbiota's composition and diversity compared to before antibitoic challenge.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 2a) Time for participants who transitioned from negative to positive VRE/EPE carriage to transition back to negative.\n- 2b) Time for the intestinal microbiota's composition and diversity to return to baseline.\n- 2c) Differences regarding detection of resistance in with conventional methods compared to metagenomic methods, defined as discordant results.","definition_or_measurement_approach":""}

Sweden

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

25-10-2024

Processing Time Days

14

Number Of Sites

2

Number Of Participants

60

Primary sponsor

Full Name

Region Uppsala

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Gävleborg county","duties_or_roles":"Source of monetary support","organisation_type":""}