EUCTR2018-001451-13-HUActive, not recruitingPhase 1
A Phase 3, Randomized, Double-blind, Active-controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults with Complicated Urinary Tract Infections, Including Acute Pyelonephritis.
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 582
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients must meet the following general inclusion criteria to be eligible for inclusion in the study:
- •1. Provide signed informed consent
- •2. Adult male and female, =18 years of age
- •3. If female, meets at least 1 of the following criteria:
- •Surgically sterile
- •Age =50 years and postmenopausal for =12 months
- •Age <50 years and postmenopausal for =2 years
- •Patient has a negative serum pregnancy test and agrees not to attempt pregnancy and, if participating in sexual activity, agrees to use an effective dual method of contraception
- •4. Patient has pyuria as demonstrated by at least 1 of the following:
- •Urine dipstick positive for leukocyte esterase
- •White blood cells (WBC) >10 cells/µL in unspun urine
- •WBC >10 cells/µL in urine sediment
- •5. Demonstrates either AP or complicated lower UTI as defined by the following criteria:
- •a. AP is indicated by the presence of both of the following criteria:
- •At least 1 of the following is present:
- •o Nausea or vomiting
- •o Chills or rigors or warmth associated with fever, defined as body temperature >38°C
- •Has flank pain or costovertebral angle tenderness
- •b. Complicated lower UTI is indicated by the presence of all 3 of the following criteria:
- •At least 1 of the following is present:
- •o Nausea or vomiting
- •o Chills or rigors or warmth associated with fever, defined as body temperature >38°C
- •At least 1 of the following signs/symptoms is present:
- •o Urinary urgency
- •o Urinary frequency
- •o Pelvic pain or suprapubic tenderness/pelvic tenderness
- •At least 1 of the following complicating factors is present:
- •o Chronic urinary retention
- •o Obstructive uropathy (if complete obstruction, should intend to relieve obstruction within 48 hours after randomization)
- •o Neurogenic bladder with presence or history of urine residual volume of >100 mL
- •o Indwelling catheter (with expectation for permanent discontinuation of the catheter by Study Day 5)
- •6. Requires IV antibacterial therapy as initial treatment for cUTI
- •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 524
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
Exclusion Criteria
- •Patients who meet any of the following general exclusion criteria will not be eligible for inclusion in the study:
- •1. Receipt of effective antibacterial drug therapy for cUTI for a continuous duration of more than 24 hours during the previous 72 hours prior to randomization
- •2. Where a urine culture result is available:
- •At least 1 uropathogen at =10^5 CFU/mL is resistant to a meropenem, or
- •A gram-negative bacterial pathogen is not identified
- •More than 2 microorganisms are isolated regardless of the colony count, or
- •The patient has a confirmed fungal UTI with colony count =10^3 CFU/mL
- •3. Requirement for use of nonstudy systemic antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with cUTI
- •4. Patients with suspected or confirmed prostatitis or urinary tract symptoms attributable to sexually transmitted disease
- •5. Patients with perinephric or renal abscess
- •6. Patients with renal transplantation or receiving hemodialysis or peritoneal dialysis
- •7. Patients with urinary diversions (e.g., ileal loops, cutaneous urostomy)
- •8. Patients who may need ongoing antibacterial drug prophylaxis after treatment of cUTI (such as vesico-ureteral reflux)
- •9. Any recent history of trauma to the pelvis or urinary tract
- •10. Patient has any urinary catheter or device or foreign body that will not be discontinued by Study Day 5, including, but not limited to, indwelling bladder catheter, urinary catheter, nephrostomy tubes, or stent
- •11. Patient is unlikely to respond to 7 days of antibacterial therapy for the treatment of cUTI without bacteremia or up to 14 days of therapy for treatment of cUTI with bacteremia
- •12. Patient has acute hepatitis, cirrhosis (Child-Pugh Class B or C), acute hepatic failure, or acute decompensation of chronic hepatic failure
- •13. Patient has had a heart, lung, heart-lung, or pancreatic transplant at any time; or bone marrow transplant in the preceding year
- •14. Patient has any of the following laboratory values:
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 calculated by Modification of Diet in Renal Disease (MDRD) formula^2
- •Hematocrit <25% or hemoglobin <8 g/dL
- •Platelet count <50,000/mm^3
- •Total bilirubin >3.0× the upper limit of normal (ULN), unless isolated hyperbilirubinemia is directly related to the acute infection or due to known Gilbert’s disease
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3.0× ULN at screening. Patients with values >3.0× ULN and <5.0× ULN are eligible if these values are acute and documented as being directly related to the infectious process being treated
- •Alkaline phosphatase >3.0× ULN. Patients with values >3.0× ULN and <5.0× ULN are eligible if this value is acute and documented as being directly related to the infectious process being treated.
- •15. Patient has a history of serious hypersensitivity (e.g., anaphylaxis), serious allergy, or any serious reaction to cephalosporin, penicillin, carbapenem, or other ß lactam antibacterials
- •16. Patient is considered unlikely to survive the 4- to 5-week study period or have a rapidly progressive or terminal illness, including septic shock, that is associated with a high risk of mortality
- •17. Patient requires concomitant medication with valproic acid or divalproex
- •18. Patient is in a situation or has a condition that, in the investigator’s opinion, may interfere with optimal participation in the study, or is unlikely to comply with protoco
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