CompletedPhase 3

Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs

Germany659 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: within 38 days after Visit 1 (=day 1)

Trial details

NCT IDNCT02639520

SponsorBionorica SE

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06

View on ClinicalTrials.gov More Urinary Tract Infection trials