Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs

NCT02639520 | Completed Phase 3

• 1 other identifier: CanUTI-7
• Study Type: interventional
• Target: 659
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection

Keywords

Uncomplicated urinary tract infection

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Group Canephron® N

ACTIVE COMPARATOR

Canephron® N \& fosfomycin trometamol-placebo

Drug: Canephron® N; Drug: Fosfomycin trometamol-placebo

Group Fosfomycin Trometamol

ACTIVE COMPARATOR

Canephron® N-placebo \& fosfomycin trometamol

Drug: Fosfomycin trometamol; Drug: Canephron® N-placebo

Interventions

Canephron® N DRUG

2 tablets 3 times a day for 7 days

Group Canephron® N

Fosfomycin trometamol DRUG

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

Group Fosfomycin Trometamol

Canephron® N-placebo DRUG

2 tablets 3 times a day for 7 days

Group Fosfomycin Trometamol

Fosfomycin trometamol-placebo DRUG

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

Group Canephron® N

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bionorica SE: lead

Study Sites (1)

Justus-Liebig-Universität

Giessen, Hesse, 35392, Germany

Location

Related Publications (1)

• 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.

  PMID: 30231252 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Fosfomycin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Florian Wagenlehner, Prof.

  Universitätsklinikum Gießen und Marburg GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 24, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 29, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

DE (1)