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Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs

Primary Purpose

Urinary Tract Infection

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Canephron® N

Fosfomycin trometamol

Canephron® N-placebo

Fosfomycin trometamol-placebo

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring Uncomplicated urinary tract infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent (IC) and data protection declaration
Female outpatients aged 18 to 70 years
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
Symptoms of the acute episode of lower uUTI are developed within not more than 6 days prior to Visit 1
Leukocyturia at Visit 1, confirmed by positive dipstick
Patients willing to refrain from consuming prohibited concomitant medications and products
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:

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.
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.).
Chronic infection of the urinary tract known from medical history.
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).
Uncontrolled hypertension (a diastolic blood pressure >95 mmHg at Visit 1).
Known severe cardiac insufficiency, coronary heart disease, valvular heart disease, cardiac arrhythmia, QT interval prolongation or other severe cardiac disease at Visit 1.
Any antibiotic therapy within 30 days prior to Visit 1.
Other acute infections (except uUTIs) requiring antibiotic treatment at Visit 1.
Patients receiving treatment for suspected or confirmed UTI (antibiotic or phytopharmaceutical) within 30 days prior to Visit 1.
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.
Known severe impaired renal function (creatinine clearance <20 mL/min).
Active peptic ulcers.

Sites / Locations

Justus-Liebig-Universität

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group Canephron® N

Group Fosfomycin Trometamol

Arm Description

Canephron® N & fosfomycin trometamol-placebo

Canephron® N-placebo & fosfomycin trometamol

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02639520

First Posted

December 11, 2015

Last Updated

July 26, 2017

Sponsor

Bionorica SE

1. Study Identification

Unique Protocol Identification Number

NCT02639520

Brief Title

Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bionorica SE

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infection

Keywords

Uncomplicated urinary tract infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

659 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group Canephron® N

Arm Type

Active Comparator

Arm Description

Canephron® N & fosfomycin trometamol-placebo

Arm Title

Group Fosfomycin Trometamol

Arm Type

Active Comparator

Arm Description

Canephron® N-placebo & fosfomycin trometamol

Intervention Type

Drug

Intervention Name(s)

Canephron® N

Intervention Description

2 tablets 3 times a day for 7 days

Intervention Type

Drug

Intervention Name(s)

Fosfomycin trometamol

Intervention Description

1 sachet of 8 g of granules; one single dose on Day 1

Intervention Type

Drug

Intervention Name(s)

Canephron® N-placebo

Intervention Description

2 tablets 3 times a day for 7 days

Intervention Type

Drug

Intervention Name(s)

Fosfomycin trometamol-placebo

Intervention Description

1 sachet of 8 g of granules; one single dose on Day 1

Primary Outcome Measure Information:

Title

Intake of any additional antibiotic medication for acute lower uUTIs between Visit 1 and Visit 4

Description

Time Frame

within 38 days after Visit 1 (=day 1)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent (IC) and data protection declaration Female outpatients aged 18 to 70 years 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 Symptoms of the acute episode of lower uUTI are developed within not more than 6 days prior to Visit 1 Leukocyturia at Visit 1, confirmed by positive dipstick Patients willing to refrain from consuming prohibited concomitant medications and products 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: 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. 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.). Chronic infection of the urinary tract known from medical history. 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). Uncontrolled hypertension (a diastolic blood pressure >95 mmHg at Visit 1). Known severe cardiac insufficiency, coronary heart disease, valvular heart disease, cardiac arrhythmia, QT interval prolongation or other severe cardiac disease at Visit 1. Any antibiotic therapy within 30 days prior to Visit 1. Other acute infections (except uUTIs) requiring antibiotic treatment at Visit 1. Patients receiving treatment for suspected or confirmed UTI (antibiotic or phytopharmaceutical) within 30 days prior to Visit 1. 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. Known severe impaired renal function (creatinine clearance <20 mL/min). Active peptic ulcers.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florian Wagenlehner, Prof.

Organizational Affiliation

Universitätsklinikum Gießen und Marburg GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Justus-Liebig-Universität

City

Giessen

State/Province

Hessen

ZIP/Postal Code

35392

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

30231252

Citation

Wagenlehner FM, Abramov-Sommariva D, Holler M, Steindl H, Naber KG. Non-Antibiotic Herbal Therapy (BNO 1045) versus Antibiotic Therapy (Fosfomycin Trometamol) for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections in Women: A Double-Blind, Parallel-Group, Randomized, Multicentre, Non-Inferiority Phase III Trial. Urol Int. 2018;101(3):327-336. doi: 10.1159/000493368. Epub 2018 Sep 19.

Results Reference

derived

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Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs

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