Alternative antibiotics to multidrug-resistant UTIs

Phase 1

• Conditions: rinary tract infection and/or bacteremia caused by extended spectrum beta-lactamases-producing Enterobacterales; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-005738-13-SE
• Lead Sponsor: Region Skåne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-04
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

All 6 of the following criteria must exist for inclusion to be made.
•Adult men and women (> 18 years) with urine and/or blood culture positive for EPE. Thus, intravenous antibiotics must have been started for patients to be included.
•Patient has received in patient care with 1-5 days of intravenous treatment with empirical antibiotics. The treating physician has considered per oral treatment safe.
•fever (= 38.0 C at least once at home or at hospital) at the emergency room (ER). Per oral therapy can be initiated regardless of temperature.
•clinical suspicion of UTI at the ER. The latter is suspected due to at least one of the following symptoms:
-flank pain
-dysuria
-positive dipstick analysis
-percussion tenderness over kidneys
•informed consent is signed by patient.
•discontinuing parenteral treatment and starting treatment with per oral antibiotics is considered safe according to treating physician.

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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

•known/suspected beta-lactam allergy.
•clinical isolate of EPE is pivmecillinam-resistant
•pregnancy
•Other reason, according to treating physician, to which patient is unfit to be included in the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: A non-inferiority trial to find a safe per oral step down treatment regimen other than ciprofloxacin and Trimetoprim-sulfamethoxazole in febrile UTIs caused by ESBL-producing Enterobacterales (EPE).;Secondary Objective: Growth of EPE in follow up urine culture (microbiological endpoint) at TOC.<br>Faecal culture positive for EPE at follow up at TOC.<br>Death from all causes within 28 days.<br>;Timepoint(s) of evaluation of this end point: 7-10 days after the end of the intervention, which is in total 5-9 days.;Primary end point(s): Primary endpoint:<br>Clinical response 7 to 10 days (test of cure, TOC) after antibiotic treatment has been discontinued. The primary endpoint is met if the patient has no symptoms (i.e. resolution of fever and dysuria > 24 h) and no further antibiotic treatment is necessary, as determined by treating physician. <br>

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 7-10 days after the end of the intervention, which is in total 5-9 days, and 28 days after the intervention.<br>;Secondary end point(s): Secondary endpoints: <br>Growth of EPE in follow up urine culture (microbiological endpoint) at TOC.<br>Faecal culture positive for EPE at follow up at TOC.<br>Death from all causes within 28 days.<br>