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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT02142751
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years old hospitalized patients
* Negative pregnancy test in fertile women
* Episode of clinically-significant monomicrobial urinary BSI due to multidrug-resistant E.coli susceptible to fosfomycin and meropenem or ceftriaxone
* Urinary sepsis with multidrug resistant E. coli isolation from the blood cultures, requires at least one clinical criteria and one of the following urinalysis criteria:
Clinical criteria
* UTI symptoms (dysuriac, urgency, suprapubic pain or pollakiuria)
* Lumbar back pain
* Cost-vertebral angle tenderness
* Altered mental status in people up to 70 years old
* Intermittent or permanent indwelling foley catheter (or withdrawal during 24 hours previous) even without urinary symptoms urinalysis criteria
* Urine dipstick test positive for either nitrites or leukocyte esterase
* Positive urine culture - Signed informed consent form (ICF) executed prior to protocol screening assessments
Exclusion Criteria:
* Polymicrobial bacteremia
* No drainage of renal abscess or obstructive uropathy unresolved
* Pregnant or careening women
* Haematogenous infection
* Other concomitant infection
* Renal transplantation recipients
* Polycystic kidney
* Hypersensitivity and/or intolerance to meropenem or fosfomycin or ceftriaxone
* Palliative care or life expectance \< 90 days
* Septic shock at time of randomization
* New York Heart Association (NYHA) functional Class IV, hepatic cirrhosis or renal impairment receiving dialysis
* Active empiric treatment \>72 hours
* Late randomization \>24 hours after multidrug resistant.coli blood culture´s identification
* Participation in other clinical trial with active treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02142751
Study Brief:
Protocol Section:
NCT02142751