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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT01505634
Eligibility Criteria:
Inclusion Criteria:
\- Clinically suspected and/or bacteriologically documented cUTI or acute
pyelonephritis judged by the investigator to be serious (requiring hospitalization and treatment with IV antibiotic therapy)
\- Pyuria, determined by a midstream clean-catch (MSCC) or catheterized
(indwelling or straight catheter) urine specimen with greater than or equal to 10 white blood cells (WBCs) per high-power field (hpf) on standard examination of urine sediment or greater than or equal to 10 WBCs/mm3 in unspun urine
\- One positive urine culture within 48 hours of enrollment
Exclusion Criteria:
\- Complete obstruction of any portion of the urinary tract (requiring a
permanent indwelling urinary catheter or instrumentation), a known ileal loop, or intractable vesico-ureteral reflux
* A temporary indwelling urinary catheter is in place and cannot be removed at study entry.
* Perinephric or intrarenal abscess or known or suspected prostatitis
* Uncomplicated UTI
* Any history of recent accidental trauma to the pelvis or urinary tract
* Any amount of effective antibiotic therapy after obtaining the urine culture for admission to this study and prior to the administration of the first dose of IV study therapy
* An infection which has been treated with greater than 24 hours of systemic antibiotic therapy known to be effective against the presumed or documented etiologic pathogen(s) within the 72-hour period immediately prior to consideration for entry into the study
* History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any
serious reaction to carbapenem antibiotics, any cephalosporins, penicillins, or other beta (β)-lactam agents
* History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to other beta-lactam inhibitors (e.g., tazobactam, sulbactam, clavulanic acid)
* History of a seizure disorder
* Currently being treated with valproic acid or has received treatment with
valproic acid in the 2 weeks prior to screening.
* Rapidly progressive or terminal illness unlikely to survive the approximately 6 to 8 week study period
* Pregnant or expecting to conceive, breast feeding, or plans to breast feed
during the study
\- A response to all study therapy (IV study therapy or subsequent oral
ciprofloxacin) within the timeframe of treatment specified in this protocol is
considered unlikely.
\- Concurrent infection that would interfere with evaluation of response to
the study antibiotics
\- Need for concomitant systemic antimicrobial agents in addition to those
designated in the various study treatment groups (use of vancomycin, daptomycin, or linezolid is allowed for certain infections)
* cUTI due to a confirmed fungal pathogen
* Currently receiving immunosuppressive therapy, including use of high-dose
corticosteroids
* Prior recipient of a renal transplantation
* Laboratory abnormalities as specified in protocol
* History of any other illness that, in the opinion of the investigator, might
confound the results of the study or pose additional risk in administering the study drug
\- Currently participating in, or has participated in, any other clinical study
involving the administration of investigational or experimental medication (not
licensed by regulatory agencies) at the time of presentation or during the previous 30 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial
\- Estimated or actual creatinine clearance of \<5 mL/minute, or is currently undergoing hemodialysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01505634
Study Brief:
Protocol Section:
NCT01505634