Clinical trial NCT05545137: Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection
Official title: Pivmecillinam Hydrochloride Tablets Versus Fosfomycin Tromethamine Granules for Uncomplicated Urinary Tract Infection in Women -A Randomized, Double-blind, Double Simulation, Positive Drug Parallel-controlled, Multi Center Phase III Clinical Trial in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uncomplicated Urinary Tract Infection
Lead sponsor: Greenpine Pharma Group Co., ltd.
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 299
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: Screening period (D -3 to D -1): complete screening examinations will be performed after the subject signs the informed consent

Dosing Treatment Period (D 1 to D 5): subjects who met the inclusion criteria and did not meet the exclusion criteria were randomized. Refer to the randomization protocol for specific randomization process.

Safety check (D 5+1): perform on-site visit after 15 doses (D 5+1)

Post-treatment follow-up assessments ((D 12±2) and (D 21+7)): subjects returned to the study site for on-site follow-up on Day 12±2 and Day 21+7.

Urine bacterial culture and minimal inhibitory concentration (MIC) test: urine bacterial culture is required for subjects.

Eligibility criteria: Inclusion Criteria:

1. Female patients over 18 years of age with uncomplicated urinary tract infection ;
2. 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;
3. 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;
4. 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;
5. Subjects who agree to participate in this clinical trial and sign a written informed consent form (ICF);

Exclusion Criteria:

1. Patients with acute or chronic upper urinary tract infection (eg, temperature \> 38 °C, chills, or costovertebral angle pain, etc.);
2. Other factors predisposing to urinary tract infection, including patients with known structural or functional abnormalities of the urinary tract such as urinary calculi;
3. Patients with indwelling catheterization or urinary incontinence;
4. 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;
5. Have taken probenecid, metoclopramide, methotrexate, aspirin, or other antimicrobial agents within 48 hours prior to dosing;
6. Have taken valproic acid or valproic acid-releasing drugs (including sodium valproate, sodium divalproex, etc.) within 48 hours prior to dosing;
7. Previous or current STDs;
8. Previous diabetes mellitus with unregulated treatment showing abnormal blood glucose ;
9. Patients allergic (including lactose intolerance) to penicillins, pivmecillinam, mecillinam, cephalosporins, fosfomycin tromethamine, or other components of the study drug;
10. Patients suspected to be unable to comply with the protocol (e.g., alcoholism, drug dependence, or poor mental status);
11. Patients have been enrolled in this trial;
12. Those who have participated in other drug interventional clinical trials or are participating in other clinical trials within 3 months prior to screening;
13. Patients who have taken study drug within the past 3 months;
14. Pregnant, lactating women, patients who are pregnant during the study or have a fertility plan within 3 months after the end of the trial;
15. Complaints of active gastric ulcer and episodes of hemorrhagic gastritis;
16. Abnormal liver and kidney function tests (ALT, AST ≥ 1.5 times the upper limit of normal, or serum creatinine ≥ 1.5 × upper limit (ULN) or creatinine clearance ≤ 50 mL/min), or other diseases that affect the efficacy of the drug as judged by the investigator ;
17. Those who are judged by the investigator to be ineligible for enrollment by clinical laboratory tests, electrocardiograms, urinary ultrasound, etc.;
18. Other reasons for inappropriate participation in the trial in the opinion of the investigator.

Primary outcomes:
measure: Change in urinary tract infection symptom score
timeFrame: From Baseline to Day 12±2
measure: Urine white blood cell count
timeFrame: Day 12±2
Secondary outcomes:
measure: Urine culture pathogen count at visit
timeFrame: Day 12±2
measure: Change in urinary tract infection symptom score
timeFrame: From Baseline to Day 5+1
measure: Urine white blood cell count
timeFrame: Day 5+1
measure: Urine culture pathogen count at visit
timeFrame: Day 5+1
measure: Change in urinary tract infection symptom score
timeFrame: From Baseline to Day 21+7
measure: Urine white blood cell count
timeFrame: Day 21+7
measure: Urine culture pathogen count at visit
timeFrame: Day 21+7
measure: Safety variables
timeFrame: Day 5+1,Day 12±2,Day 21+7
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing hospital
state: Beijing
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region People's Hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: The second hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Humanity Rehabilitation hospital
state: Hunan
city: Loudi
country: China
facility: Loudi Central Hospital
state: Hunan
city: Yueyang
country: China
facility: Yueyang people's Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiangdong Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: