Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT02959957
Eligibility Criteria:
Inclusion Criteria:
* Males and females ≥ 18 years of age with suspected or confirmed febrile UTI, fulfilling at least one of the following signs and symptoms:
* Flank pain or suprapubic pain, Tenderness over the kidney on physical examination, Urinary symptoms such as dysuria, urinary frequency or urinary urgency
* Fever ≥ 38.0°C (highest temperature recorded at home or at the hospital)
* Positive urinalysis tests (U-Nitrit and/or U-LPK)
* Have a pre-treatment baseline urinary culture obtained
* Require iv antibacterial treatment of the presumed infection
* Fertile women: Agree to practice highly effective anti-contraceptive methods from study-start to TOC
* Signed informed consent
Exclusion Criteria:
* Have a documented history of hypersensitivity or allergic reaction to any beta-lactam
* Pregnant or nursing women
* Receipt of any prior potentially therapeutic antibacterial agent within 1 month before randomisation and sampling for urine and faecal cultures. Exceptions will prior treatment with pivmecillinam or nitrofurantoin.
* Known chronic renal insufficiency (creatinine clearance \< 10 mL/min at screening as estimated by Cockcroft-Gault), or receiving intermittent haemodialysis or peritoneal dialysis
* Known colonization with ESBL
* Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02959957
Study Brief:
Protocol Section:
NCT02959957