Single-site, open, randomized clinical trial to assess the non-inferiority of Cysticlean® versus Fosfomicina in the treatment of cystitis in women in Spain.

• Register: EUCTR
• Last refreshed on: 12 March 2024
• Main ID: EUCTR2018-001448-78-ES
• Date of registration: 25/10/2018
• Prospective Registration: Yes
• Primary sponsor: Vita Green Europa S.A.
• Public title: Single-site, open, randomized clinical trial to assess the non-inferiority of Cysticlean® versus Fosfomicina in the treatment of cystitis in women in Spain.
• Scientific title: Single-site, open, randomized clinical trial to assess the non-inferiority of Cysticlean® versus Fosfomicina in the treatment of cystitis in women in Spain.
• Date of first enrolment: 08/11/2018
• Target sample size: 128
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-001448-78
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Spain

Contacts

• Name: Dr. Xavier Gras
• Affiliation: Vita Green Europa S.A.

• Name: Dr. Xavier Gras
• Affiliation: Vita Green Europa S.A.

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Urinary Tract Infection (UTI)
MedDRA version: 20.1 Level: PT Classification code 10011790 Term: Cystitis escherichia System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Intervention(s)

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: CRANBERRY
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Trade Name: Fosfomycin
Product Name: Fosfomycin
Product Code: Fos
Pharmaceutical Form: Capsule
INN or Proposed INN: FOSFOMYCIN TROMETAMOL
Current Sponsor code: Fosfomycin
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 3-

Primary Outcome(s)

Secondary Objective: Assessment of the incidence of patients with resistance to Fosfomycin in the overall sample.

Main Objective: Assessment of non-inferiority of Cysticlean® versus Fosfomycin in the treatment of cystitis caused by Escherichia coli in women.

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 Outcome(s)

Timepoint(s) of evaluation of this end point: At 2-3 days

Secondary end point(s): Percentage of patients with resistance to Fosfomycin in the overall sample.

Secondary ID(s)

Cyst2018_01

Source(s) of Monetary Support

Vita Green Europa S.A.

Ethics review

Status: Approved
Approval date: 29/10/2018
Contact: