Uncomplicated recurrent urinary tract infections MedDRA version: 9.1 Level: LLT Classification code 10038140 Term: Recurrent urinary tract infection
Conditions
Interventions
Trade Name: Uro-Vaxom®
Pharmaceutical Form: Capsule*
Current Sponsor code: OM-89-S, AP-89
Other descriptive name: Escherichia Coli, lyophilized
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Alita Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient must meet the following criteria at Screening (Visit 1) to participate in this study: I.1 Ambulatory female aged 18 to 73 years I.2 Acute uncomplicated UTI at Screening, including at least one of the following symptoms persisting for at least one day: dysuria, increased frequency, increased urgency, or suprapubic pain I.3 If of child-bearing potential, must agree to use an adequate, consistent form of contraception during the study [e.g., oral contraceptives or hormone-containing intra-uterine device use during the study at the same dose and regimen and for at least 90 days prior to study start; abstinence, sterilization of self or partner, or any other contraceptive method(s) not prohibited by the protocol with a Pearl index =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will be excluded from participating in the study at Screening (Visit 1) and unless noted otherwise, Randomization (Day 0/Visit 2) for any of the following reasons: E.1 History of more than 10 UTIs in the year before Screening meeting the documented historical UTI definition E.2 Long-term (>30 days continuous therapy) or frequent intermittent (>14 days/month for a non-UTI indication) anti-infective use in the 90 days before Screening E.3 History of interstitial cystitis, inflammatory bowel disease, or chronic enteropathies E.4 Functional and structural abnormalities within the urinary tract or obstructive morphological changes as documented in the patient’s medical history E.5 History of persistent UTIs (i.e., history of at least 2 UTIs meeting the documented historical UTI definition lasting = 14 days in the year prior to Screening) E.6 Use of a urinary catheter within 90 days prior to Screening, however, transient (“in and out”) catheterization by a qualified medical professional using accepted catheterization techniques (i.e., perineal preparation) for the purposes of collection of an adequate bladder sample is acceptable E.7 Known symptoms of neurogenic bladder dysfunction, as manifested either by the presence of a neurological condition (e.g., spinal cord injury) that is associated with neurogenic bladder dysfunction or known abdominal urodynamic studies (voiding cystourethrogram, cystometry) consistent with the diagnosis of neurogenic bladder dysfunction E.8 Abnormal clinically significant laboratory values, as determined by the investigator, at Screening E.9 Severe cardiovascular disease (e.g., left ventricular failure, stroke) E.10 Significant liver insufficiency — i.e., AST and ALT > 2xULN E.11 Renal disease, pyelonephritis, or significant renal insufficiency (i.e., serum creatinine > 1.5 mg/dL [133 µmol/L]) E.12 Malignant disease within 5 years of entering the study (excluding basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix treated with cryosurgery or conization, or isolated cutaneous melanomas <5 mm in the longest diameter) E.13 Active autoimmune disease and other systemic diseases related to immune system disorders (except diabetes mellitus with controlled blood glucose levels during the 90 days prior to Screening, as determined by the investigator) E.14 Pregnant, lactating, or planning to become pregnant E.15 Unreliable or non-compliant, including patients with known history of alcoholism, drug abuse, or serious psychiatric disorder; as well as patients unwilling to abide by the requirements of the protocol E.16 Major surgical procedure, registered pharmaceutical immunomodulatory therapy for indications other than UTI, use of any experimental drug or device, or participation in another clinical trial within the 90 days prior to Screening E.17 Exposure to any registered pharmaceutical immunomodulatory therapy for UTI [e.g., Uro-Vaxom® (also known as OM-89/OM-89S/AP-89) or StroVac®] or Subreum® within 1 year prior to Screening E.18 Anticipated antibiotic use during the study, except for the treatment of acute UTI E.19 Use of hormone replacement therapy or cranberry products for less than the 90 days prior to Screening. [Use of these products is allowed IF the dose and regimen remain constant at least 90 days before Screening and for the duration of the study.] E.20 Any condition, as determined by the investigator, that would interfere with the patient’s ability to c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy evaluation will be time to first recurrence of a qualifying UTI (i.e., at least one of the following symptoms persisting for at least one day: dysuria, increased frequency, increased urgency, or suprapubic pain; and bacterial count of =10^3 CFU/mL of at least one species) between the two active arms (pooled) versus placebo. The primary evaluation will be supported by pairwise comparisons among the three treatment groups.;Secondary Objective: Secondary efficacy objectives include: • Rate of UTI cases • Rate of UTI cases categorized by the following at baseline: number of qualifying historical UTIs, previous use of Uro-Vaxom®, and menopausal status • Rates of UTI cases by study period (treatment period versus follow-up period) • Impact of using an alternative bacterial count definition of a UTI; =10^3 versus =10^5 CFU/mL • Effect of anti-infective use on UTI rate • Bacterial distribution of E. coli and non-E. coli infections • Exploratory evaluation of relationship between rate of UTIs and: - Lewis phenotype; - Periurethral/introital gram-negative bacterial colonization; - Intravaginal/urinary sIgA levels; - Serum IgA, IgE, IgG, and IgM levels; - B- and T-lymphocyte levels; and - Cytokine release profile of PBMCs; As well as the incidence of bacteriuria. Secondary safety objectives include: • Physical examinations • Vital signs • Laboratory tests • Adverse events and serious adverse events;Primary end point(s): The primary efficacy analysis will be based upon the time to first recurrence of a qualifying UTI (i.e., at least one of the following symptoms persisting for at least one day: dysuria, increased frequency, increased urgency, or suprapubic pain; and bacterial count of =10^3 CFU/mL of at least one species) between the two active arms (pooled) versus placebo. | — |
Countries
Germany
Outcome results
None listed