Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs

Urinary Tract Infection Clinical Trial

Official title:

A Double-blind, Controlled, Parallel-group, Randomized, Multicenter Clinical Trial to Assess the Efficacy and Safety of a Herbal Drug Containing Centaury, Lovage Root and Rosemary Leaf (CLR) in Comparison to Fosfomycin Trometamol for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections (uUTIs) in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639520
• Other study ID #: CanUTI-7
• Status: Completed
• Phase: Phase 3
• First received: December 11, 2015
• Last updated: July 26, 2017
• Start date: December 2015
• Est. completion date: June 29, 2017

Study information

• Verified date: July 2017
• Source: Bionorica SE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate non-inferiority of a non-antibiotic therapy with CLR versus an antibiotic treatment with fosfomycin trometamol in women suffering from acute lower uUTIs as measured by the proportion of patients who received an additional antibiotic treatment for acute lower uUTIs during the trial.

Description:

The trial is designed as a comparison of two different modes of action in order to look for alternatives to antibiotic treatment of uncomplicated UTIs. Treatment with CLR is a nonantibiotic therapy and is compared to an antibiotic treatment. Thus, the trial aim is to reduce antibiotics use and moreover to reduce the pressure of developing bacterial resistance against antibiotics due to widespread use, which is an additional advantage of the CLR therapy.

The trial results are expected to demonstrate that antibiotic prescriptions in women for treatment of lower uUTIs can be reduced by an alternative and safe non-antibiotic treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 659
• Est. completion date: June 29, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent (IC) and data protection declaration

2. Female outpatients aged 18 to 70 years

3. Sum-score of the main uUTI symptoms (dysuria, pollakisuria, and urgency) reported on the Acute Cystitis Symptom Score (ACSS)-"Typical" domain at Visit 1 is =6

4. Symptoms of the acute episode of lower uUTI are developed within not more than 6 days prior to Visit 1

5. Leukocyturia at Visit 1, confirmed by positive dipstick

6. Patients willing to refrain from consuming prohibited concomitant medications and products

7. Non-lactating female patients who are surgically sterile (have had a documented sterilization, bilateral oophorectomy at least 3 months before the start of the trial and/or hysterectomy), or postmenopausal (cessation of menses for at least 12 months), or women of childbearing potential with a negative pregnancy test at Visit 1 willing to use highly effective (failure rate less than 1% per year, i.e., Pearl Index <1) contraception methods, e.g., contraceptive patch, oral, injected or implanted hormonal methods of contraception, during the trial including the follow-up period.

Exclusion Criteria:

1. Any signs of complicated urinary tract infections (UTIs), pyelonephritis (i.e., fever T =38.0°C [grade 2], flank and/or back pain, chills and shivers), and/or vulvo-vaginitis with vaginal and/or with urethral discharge (without urination) at Visit 1.

2. Any conditions that may lead to complicated infections (i.e., renal diseases, urinary tract abnormalities or past urinary surgery, urine catheterization, uncontrolled diabetes mellitus, spinal cord injury, etc.).

3. Chronic infection of the urinary tract known from medical history.

4. Persisting signs or symptoms of severe, progressive, or uncontrolled systemic disease (i.e., renal, hepatic, biliary, hematological, gastro-intestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease).

5. Uncontrolled hypertension (a diastolic blood pressure >95 mmHg at Visit 1).

6. Known severe cardiac insufficiency, coronary heart disease, valvular heart disease, cardiac arrhythmia, QT interval prolongation or other severe cardiac disease at Visit 1.

7. Any antibiotic therapy within 30 days prior to Visit 1.

8. Other acute infections (except uUTIs) requiring antibiotic treatment at Visit 1.

9. Patients receiving treatment for suspected or confirmed UTI (antibiotic or phytopharmaceutical) within 30 days prior to Visit 1.

10. Patients who took anti-inflammatory drugs (e.g., ibuprofen) or spasmolytics for any reason within 24 hours prior to Visit 1, and/or are not willing to stop the intake of any of the medication not permitted for use during the trial.

11. Known severe impaired renal function (creatinine clearance <20 mL/min).

12. Active peptic ulcers.

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Canephron® N
2 tablets 3 times a day for 7 days
• Fosfomycin trometamol
1 sachet of 8 g of granules; one single dose on Day 1
• Canephron® N-placebo
2 tablets 3 times a day for 7 days
• Fosfomycin trometamol-placebo
1 sachet of 8 g of granules; one single dose on Day 1

Locations

Country	Name	City	State
Germany	Justus-Liebig-Universität	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Bionorica SE

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intake of any additional antibiotic medication for acute lower uUTIs between Visit 1 and Visit 4	For patients with consistent or worsening of acute lower uUTI symptoms during the trial the investigator may offer an additional antibiotic therapy at any post-baseline visit. In this case, the patient will be considered a "treatment failure" due to lack of efficacy of the IMP. The alternative antibiotic therapy offered to the patient and the reason for the alternative therapy (i.e., persisting or recurrent symptoms) is to be documented.; The primary variable for the assessment of efficacy is the proportion of patients who received additional antibiotic treatment for acute lower uUTI between Visit 1 and Visit 4 (defined as AB-rate).	within 38 days after Visit 1 (=day 1)