Urinary Tract Infection (UTI) MedDRA version: 20.1 Level: PT Classification code 10011790 Term: Cystitis escherichia System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Cysticlean
Product Name: Cysticlean
Product Code: Cyst
Pharmaceutical Form: Capsule
INN or Proposed INN: cranberry extract
Current Sponsor code: Cyst2018_01
Other descriptive name: CRANBER
Sponsors
Vita Green Europa S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women aged between 18 and 64 years. 2. With at least of two of the following signs / symptoms of cystitis: Dysuria, Stinging, Hematuria, Frequent, Urinary urgency 3. Cystitis caused by Escherichia coli 4. Written informed consent to participate in this clinical trial. 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 128 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Malaise 2. Currently receiving or has received antibiotics for any reason in the last month before entering the study 3. Active treatment with warfarin 4. Allergy to cranberry or any component of Cysticlean® or Fosfomycin 5. History of repeated episodes of acute pyelonephritis during the last year 6. Chills, malaise, fever or temperature higher than 37°C 7. Known morphological abnormalities of the urinary tract 8. Patients with known coagulation disorder 9. Women no to take highly effective contraceptive 10. Immunocompromised patients 11. Patients with urinary tract infection that is not caused by Escherichia coli 12. Patients with advanced cancer or with treatment 13. Patients with severe renal impairment 14.Patients undergoing hemodialysis 15. Patients who are allergic to acetylsalicylic acid 16. Patients taking metocloparamida 17. Participation in another interventional clinical study that could interfere with the results of this trial 18. In the investigator's opinion, is unable to meet the requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of non-inferiority of Cysticlean® versus Fosfomycin in the treatment of cystitis caused by Escherichia coli in women.;Secondary Objective: Assessment of the incidence of patients with resistance to Fosfomycin in the overall sample.;Primary end point(s): Percentage of patients without "treatment failure", defined failure as (presence of at least one of the following): - Patient reported symptoms / signs of cystitis persist during the test - Patient should take a new dose of Fosfomycin at some point during the study - Change of treatment for the cystitis during the study - Escherichia coli positive urine culture (>100.000 cfu) at the end of the trial;Timepoint(s) of evaluation of this end point: At 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients with resistance to Fosfomycin in the overall sample.;Timepoint(s) of evaluation of this end point: At 2-3 days | — |
Countries
Spain
Contacts
Public ContactDr. Xavier Gras
Vita Green Europa S.A.
Outcome results
None listed