Lower Uncomplicated Urinary Tract Infection MedDRA version: 17.1 Level: LLT Classification code 10024981 Term: Lower urinary tract infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Selexid 400 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: PIVMECILLINAM
CAS Number: 32886-97-8
Other descriptive name: pivmecillinamhydrochlorid
Concentration unit: mg milligr
Sponsors
Department of Clinical Microbiology, Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women in the age of 18-70 years old, with clinical features of community acquired uncomplicated UTI and ability to understand the study and give written consent. Patients should have a symptom cumulative score of = 2 p (i.e. none, mild, moderate or severe, scoring 0-3, respectively) in accordance to the validated questionnaires for uncomplicated UTI. The following signs and symptoms are included: • Dysuria (i.e. pain or burning sensation on urination) • Urgency (i.e. feeling an increased and more frequent need to urinate) • Pollakisuria/frequency (i.e. urinating more frequently than usually) An accepted definition of uncomplicated urinary tract infections is symptoms in concordance with uUTI and significant bacteriuria of uropathogenic bacteria1, but we have chosen not include the latter criteria in our ITT analysis. This is because we want the included patients in the ITT group to mimic the realistic settings as much as possible (i.e. in which patients with uUTI will receive antibiotic therapy without urine samples in most primary care settings). 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 425 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: Absolute exclusion criteria are: • Clear signs of pyelonephritis (high fever =38,5°C or back/flank pain), or high suspicion of pyelonephritis • Allergy to penicillins Symptom related exclusion criteria: • Clear vaginal symptoms, i.e. discharge and/or pain Any condition that may lead or predispose to complicated urinary infection: • Indwelling urinary catheter • Pregnancy • Immunosuppressive therapy • Abnormal/pathological urinary tracts (e.g. renal disease, known presence of urinary stones, past urinary interventions/surgery, genetic aciduria) • Hard treated recurrent UTIs • Serious neurological disease affecting the bladder (i.e. paraplegia, multiple sclerosis, epilepsy) Other complicating or contradictive conditions: • Ongoing breastfeeding • Ongoing/current antibiotic therapy • Oesophageal stricture • Current intake of allopurinol (i.e. increases the risk of allergic skin reaction to mecillinam) or probenecid (i.e. decrease the renal excretion of mecillinam) • Currently part of another clinical trail • Unwilling to participate in study (i.e. not wanting to sign consent form) • Inability/unable to understand and/or take part in the clinical trial • Incapable of following the instructions of the study There are no known drugs beside those listed in the exclusion criteria to have significant interaction with mecillinam. Thus, all other drugs (prescribed or non-prescription) should be taken as usual throughout the study (which will be explained by the GP). However, all drugs should be registered in the diary and/or given permission by the patient for us to look it up on the national database of medicine prescriptions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Identify and compare the efficacy of pivmecillinam 400 mg t.i.d in a 3-day respectively 5-day regimen, against community acquired lower urinary tract infections i.e. in women at the age of 18-70 years old.;Secondary Objective: Not applicable;Primary end point(s): We have 2 co-primary endpoints Co-primary endpoint no. 1 – initial clinical cure (i.e. what group experience clinical cure fastest). Co-primary endpoint no. 2 – initial bacteriological cure rate (i.e. control urine sample no. 1 compared to pre-treatment urine sample). ;Timepoint(s) of evaluation of this end point: Both primary endpoints will be evaluated at the intervene analysis (i.e. the first 300 included patients to see if there is a large difference that will make it unethical for us to proceed with the study), and finally at the end of the trail (i.e. after the last patient is included | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinical signs and symptoms in uncomplicated urinary tract infections in women. 2. Frequency and timing of relapse of symptoms and/or bacteriuria. 3. Bacteriological findings (i.e. ESBL producing bacteria) 4. Complications (i.e. urosepsis and/or pyelonephritis) ;Timepoint(s) of evaluation of this end point: All secondary endpoints will be evaluated at the intervene analysis (i.e. the first 300 included patients to see if there is a large difference that will make it unethical for us to proceed with the study), and finally at the end of the trail (i.e. after the last patient is included | — |
Countries
Denmark
Contacts
Public ContactDepartment of Clinical Microbiology
Department of Clinical Microbiology, Hvidovre Hospital
Outcome results
None listed