None listed
Conditions
Interventions
Intervention1: Uro-Vaxom: 6 mg capsule OD for 3 months
Control Intervention1: Placebo:
6 mg od for 3 months
Sponsors
Ranbaxy Laboratories Ltd.,
Plot No.20, Sector 18,
Gurgaon - 122015 , Haryana
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients (more than equal to, 18 years of age of either sex) with clinical signs and symptoms of UTI (viz., dysuria, frequency, urgency and/or suprapubic pain) with onset of symptoms more than equal to 72 hrs prior to study entry. One positive pre-treatment clean-catch midstream urine culture, within 48 hrs of enrollment in the study, should demonstrate ≥ 105 CFU/ml of uropathogens*. History of recurrent urinary tract infections (at least 3 documented episodes in the previous 12 months) other than the current episode *Uropathogens that cause UTI will include: Escherichia coli and Staphylococcus saprophyticus. Less common organisms include Proteus mirabilis, Klebsiella pneumoniae, Enterobacter spp, Pseudomonas and Enterococcus spp.
Exclusion criteria
Exclusion criteria: Patients with history of hypersensitivity to Uro-Vaxom. Pregnant or breast-feeding women or women with positive urine pregnancy test at screening. Patients with history of factors predisposing to the development of urinary tract infections, including calculi, stricture, tumor(s), ureteric stent, nephrostomy tubes, pelvicalyceal junction obstruction, bladder diverticuli, neurogenic bladder or urological surgery. Patients with an indwelling urinary catheter or intermittent urinary catheterization. Present or past history of any malignant disease. History of autoimmune disorder(s) (e.g. rheumatoid arthritis, ankylosing spondylitis, systemic lupus erhythematosus, Sjogren?s syndrome, Graves disease, Addison's disease, Crohn's disease etc). Administration of drugs (e.g. immunostimulants, immunosuppressive agents) interfering with immune system in past three months. Patients on long-term antibiotic therapy. However, patients on maintenance therapy for recurrent UTI and not controlled can be enrolled after antibiotic therapy has been stopped for 7 days prior to enrollment in this study. Patients with clinically significant cardiovascular, renal, hepatic, gastrointestinal (including patients with inability to take oral medication or those with vomiting), uncontrolled diabetes mellitus (fasting blood sugar >300 mg/dL), neurological, psychiatric, respiratory or hematological diseases. Patients with values for SGPT or SGOT >2 times upper limit of normal (ULN), serum bilirubin or alkaline phosphatase (ALP) >1.2 times ULN or serum creatinine > 1.6 mg/dl. Patients with any condition or concomitant infection, which in the opinion of the investigator could preclude evaluation of response. Patients with known alcohol or drug abuse. Patients unwilling to give the written informed consent or to abide by the requirements of the protocol. Participation in another clinical trial within the last 3 months prior to entry in this study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with 0, 1, 2-3 and ≥ 4 UTI episodes Duration and intensity of signs and symptoms. Duration of prescribed concomitant antibiotics. Global assessment of overall efficacy by physician and patient. Timepoint: At end of 24 weeks. | — |
Primary
| Measure | Time frame |
|---|---|
| Difference in the number of UTI episodes between the placebo and the Uro-Vaxom group at the end of 24 weeks.Timepoint: At the end of 24 weeks | — |
Countries
India
Contacts
Public ContactMonika Obrah
Outcome results
None listed