Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary T… (NCT05545137) | Clinical Trial Compass
CompletedPhase 3
Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection
China299 participantsStarted 2022-09-29
Plain-language summary
the purpose of this study is to evaluate the efficacy and safety of pivmecillinam hydrochloride tablets in the treatment of uncomplicated urinary tract infection in China
Who can participate
Age range18 Years
SexFEMALE
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
✓. Female patients over 18 years of age with uncomplicated urinary tract infection ;
✓. Within 72 hours prior to study entry, the following symptoms or signs occurred: frequency of urine, urgency, dysuria (including suprapubic pain, pain or burning sensation on urination), dysuria, and symptom score ≥ 2 points;
✓. Urinalysis showed leukocyturia, i.e.,white blood cells≥ 10/μl on non-centrifuged urinalysis and white blood cell count greater than the upper limit of normal at the study site or white blood cells\>5 /HP（high-power） on microscopic examination of urine sediment;
✓. Those who have no childbearing plan within the past 6 months (women of childbearing potential have a negative urine pregnancy test result at screening or within 72 hours before starting the trial) and agree to use effective non-drug contraception during the study;
✓. Subjects who agree to participate in this clinical trial and sign a written informed consent form (ICF);
Exclusion criteria
✕. Patients with acute or chronic upper urinary tract infection (eg, temperature \> 38 °C, chills, or costovertebral angle pain, etc.);
✕. Other factors predisposing to urinary tract infection, including patients with known structural or functional abnormalities of the urinary tract such as urinary calculi;
✕. Patients with indwelling catheterization or urinary incontinence;
✕. Patients who have taken drugs for treatment of urinary tract infection or antibiotics for other diseases within 48 hours prior to dosing are excluded if the half-life of antibiotics taken by the subject is long and cannot be basically cleared before dosing as judged by the investigator, even if they have not taken any antibiotics within 48 hours prior to randomization;
What they're measuring
1
Change in urinary tract infection symptom score
Timeframe: From Baseline to Day 12±2
2
Urine white blood cell count
Timeframe: Day 12±2
Trial details
NCT IDNCT05545137
SponsorBenova (Tianjin) Innovative medicine Research Co., Ltd.