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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT03891433
Eligibility Criteria:
Inclusion Criteria:
* Adults (≥18 years) with hospital admission for non-bacteremic UTI caused by E. coli or K. pneumoniae ESBL susceptible to piperacillin/tazobactam and carbapenems.
* Presence of any risk factor associated with UTI due to ESBL germs: older age 64 years, diabetes mellitus, bladder catheter, previous antibiotics in the last 6 months, hospitalization in the last 6 months, urological surgery in the last 30 days, infections recurrent urinary.
* Diagnosis of UTI confirmed by: 1) fever, 2) urine culture\> 100000 CFU with isolation E. coli or K. pneumoniae ESBL susceptible to piperacillin / tazobactam and carbapenems, and 3) lumbar and / or abdominal pain with or without low urinary symptoms (dysuria, tenesmus, urgency), and 4) no other cause that explains the patient's symptoms
* Signed informed consent.
* Negative pregnancy test in fertile women.
Exclusion Criteria:
* Non-acceptance of participation in the study.
* Pregnancy.
* Hypersensitivity and/or previous intolerance to penicillins, piperacillin/tazobactam or carbapenems.
* Bacteremia, hematogenous infection or other concomitant infection.
* Immunosuppression.
* In case of obstructive uropathy, lack of early surgical resolution.
* Evidence of acute or chronic prostatitis.
* Renal abscess
* Polycystic disease in the kidneys.
* Palliative care or life expectancy \<90 days.
* Heart failure (NYHA) functional class III or IV.
* Liver cirrhosis.
* Renal insufficiency in dialysis treatment.
* Empirical active treatment against bacteria isolated by urine cultures other than E. coli or K. pneumoniae BLEE.
* Participation in another clinical trial for infections.
* Hypersensitivity to amide-type local anesthetics.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03891433
Study Brief:
Protocol Section:
NCT03891433