Single-site, open, randomized clinical trial to assess the non-inferiority of Cysticlean® versus Fosfomicina in the treatment of cystitis in women in Spain.
- Conditions
- rinary Tract Infection (UTI)MedDRA version: 20.1Level: PTClassification code 10011790Term: Cystitis escherichiaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2018-001448-78-ES
- Lead Sponsor
- Vita Green Europa S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 128
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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):<br>- Patient reported symptoms / signs of cystitis persist during the test<br>- Patient should take a new dose of Fosfomycin at some point during the study<br>- Change of treatment for the cystitis during the study<br>- 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 Outcome Measures
Name Time Method 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