Uncomplicated recurrent lower urinary tract infection in female patients
Conditions
Interventions
Group 1: Treatment with Kineret® (Anakinra)
Group 2: Treatment with Nitrofurantoin
Sponsors
SelectImmune Pharma AB (Lund, Schweden)Org nr: 559104-6874
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Stable patients with an acute episode of recurrent uncomplicated cystitis; Signed written informed consent; Ability and willingness to comply with study procedures; Adult female patients = 18 - 65 years; Negative urine pregnancy test in women of childbearing age; Sum score of major symptoms of UUTI reported on the ACSS typical domain (Acute Cystitis Symptom Score) at visit 1 = 6; Typical symptoms must be acute and develop within = 6 days; History of recurrent cystitis (= 3 documented episodes in the history in the past year) or (= 2 documented episodes in the history in the past 6 months)); Contraception should be maintained during treatment and 30 days after the last dose. Women of childbearing age must use contraceptive methods that are considered highly effective methods of birth control. Such methods include: combined (estrogen and progestin) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal, or progesterone-only hormonal contraception associated with inhibition of ovulation: Oral, injectable, implantable, and intrauterine device (IUD), intrauterine hormone release system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence. Hormonal contraceptive methods should be combined with barrier methods.
Exclusion criteria
Exclusion criteria: Breastfeeding; Signs of pyelonephritis; Uncontrolled diabetes mellitus; Neutropenia (<1.5x10 9/L); Signs of genital infections (vaginitis/cervicitis); History exclusion of patients with active severe infections, history of viral hepatitis (only anamnestic exclusion possible, as immediate inclusion in the study is urgently required for this disease pattern. Serological and other blood test results (processing time = 24 hours) cannot be waited for); Patients using CYP450 drugs (e.g. warfarin, phenytoin); Patients using phenytoin medications; History exclusion of patients with history of tuberculosis or active tuberculosis (only anamnestic exclusion possible, as immediate inclusion in the study is urgently required for this disease pattern. Serological and other blood test results (processing time = 24 hours) cannot be waited for); Extragenital conditions, nephrologic conditions, urologic conditions, urinary catheters that may lead to complicated urinary tract infection; Severe uncontrolled systemic disease; Systemic antibiotic therapy within 5 days prior to enrollment; Impaired renal function (creatinine clearance < 60 ml /min); Known allergies/contraindications to Kineret® and nitrofurantoin or their other components or to proteins derived from E. coli; Malignant diseases; Immunosuppression; Pathological liver enzymes; Polyneuropathies; Glucose-6-phosphate dehydrogenase deficiency; Previously participated in this study; Participation in other interventional clinical trials; No use of diclofenac and ibuprofen as analgesics during participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in symptom score as measured by the ACSS in the first 5 days (ACSS dynamics) | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacteriuria at visits up to 26 weeks; Leukocyturia at visits up to 26 weeks; Recurrent urinary tract infections up to 6 months | — |
Countries
Germany
Contacts
Public ContactFlorian Wagenlehner
Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie
Outcome results
None listed