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Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection

Primary Purpose

Uncomplicated Urinary Tract Infection

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pivmecillinam hydrochloride tablets
Fosfomycin Tromethamine Granules
Sponsored by
Benova (Tianjin) Innovative medicine Research Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncomplicated Urinary Tract Infection

Eligibility Criteria

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

Inclusion Criteria:

  1. Female patients aged 18 to 70(inclusive) years with uncomplicated urinary tract infection ;
  2. At least 2 of the following symptoms or signs within 72 hours prior to study entry: frequent urgency, dysuria (including suprapubic pain, pain or burning sensation), dysuria;
  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 who complained of frequent symptoms of diarrhea at screening (more than 3 episodes of diarrhea in the past 1 month);
  4. Patients with indwelling catheterization or urinary incontinence;
  5. 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;
  6. Have taken probenecid, metoclopramide, methotrexate, aspirin, or other antimicrobial agents within 48 hours prior to dosing;
  7. Have taken valproic acid or valproic acid-releasing drugs (including sodium valproate, sodium divalproex, etc.) within 48 hours prior to dosing;
  8. Patients with immunosuppression, neurological disorders, or venereal diseases;
  9. Patients with a previous diagnosis of diabetes mellitus, nephropathy or confirmed by laboratory tests;
  10. Patients allergic (including lactose intolerance) to penicillins, pivmecillinam, mecillinam, cephalosporins, fosfomycin tromethamine, or other components of the study drug;
  11. Patients suspected to be unable to comply with the protocol (e.g., alcoholism, drug dependence, or poor mental status);
  12. Patients have been enrolled in this trial;
  13. Those who have participated in other drug interventional clinical trials or are participating in other clinical trials within 3 months prior to screening;
  14. Patients who have taken study drug within the past 3 months;
  15. Pregnant, lactating women, patients who are pregnant during the study or have a fertility plan within 3 months after the end of the trial;
  16. Complaints of active gastric ulcer and episodes of hemorrhagic gastritis;
  17. History of congestive heart failure, uncontrolled hypertension (resting sitting systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg on 2 or more consecutive occasions), uncontrolled coronary heart disease, or arrhythmia;
  18. History of blood diseases (neutrophil count ≤ 1.5 × 10^9/L; platelets ≤ 75 × 10^9/L; blood chemistry criteria: alanine transferase, aspartate transferase, alkaline phosphatase, gamma-glutamyl transpeptidase, any of which is ≥ 2.5 × upper limit (ULN); serum total bilirubin ≥ 1.5 × upper limit (ULN); serum creatinine ≥ 1.5 × upper limit (ULN) or creatinine clearance ≤ 50 mL/min) and liver, neuropathy, psychosis, kidney that affect the efficacy of the drug as judged by the investigator;
  19. Those who are judged by the investigator to be ineligible for enrollment by clinical laboratory tests, electrocardiograms, urinary ultrasound, etc.;
  20. Other reasons for inappropriate participation in the trial in the opinion of the investigator.

Sites / Locations

  • Beijing hospitalRecruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • The second hospital of Hebei Medical UniversityRecruiting
  • Xiangya Humanity Rehabilitation hospitalRecruiting
  • Loudi Central HospitalRecruiting
  • Yueyang people's HospitalRecruiting
  • Jiangsu Provincial Hospital of Integrated Chinese and Western MedicineRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Yantai Yuhuangding hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pivmecillinam hydrochloride tablets treatment group

Fosfomycin Tromethamine Granules treatment group

Arm Description

participants received Pivmecillinam Hydrochloride Tablets + Fosfomycin Tromethamine Granules Simulant. Pivmecillinam Hydrochloride Tablets:oral,One tablets each time,3 times a day for five days. Fosfomycin Tromethamine Granules Simulant :oral, 1 pack, only once for the entire course of treatment

participants received Fosfomycin Tromethamine Granules + Pivmecillinam Hydrochloride Tablets Simulant Fosfomycin Tromethamine Granules:oral, 1 pack, only once for the entire course of treatment. Pivmecillinam Hydrochloride Tablets Simulant :oral,One tablets each time,3 times a day for five days.

Outcomes

Primary Outcome Measures

Change in urinary tract infection symptom score
The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms). Change = (Day 12±2 Score - Baseline Score)
Urine white blood cell count
Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.

Secondary Outcome Measures

Urine culture pathogen count at visit
The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to< 10^3 CFU(Colony-Forming Unit)/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).
Change in urinary tract infection symptom score
The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, Urinary pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms). Change = (Day 12±2 Score - Baseline Score)
Urine white blood cell count
Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.
Urine culture pathogen count at visit
The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to<10^3 CFU/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).
Change in urinary tract infection symptom score
The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, Urinary pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms). Change = (Day 12±2 Score - Baseline Score)
Urine white blood cell count
Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.
Urine culture pathogen count at visit
The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to<10^3 CFU/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).
Safety variables
Safety variables: adverse events reported by the patient at the visit or occurred during the trial.

Full Information

First Posted
September 2, 2022
Last Updated
July 6, 2023
Sponsor
Benova (Tianjin) Innovative medicine Research Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05545137
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Benova (Tianjin) Innovative medicine Research Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Urinary Tract Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pivmecillinam hydrochloride tablets treatment group
Arm Type
Experimental
Arm Description
participants received Pivmecillinam Hydrochloride Tablets + Fosfomycin Tromethamine Granules Simulant. Pivmecillinam Hydrochloride Tablets:oral,One tablets each time,3 times a day for five days. Fosfomycin Tromethamine Granules Simulant :oral, 1 pack, only once for the entire course of treatment
Arm Title
Fosfomycin Tromethamine Granules treatment group
Arm Type
Active Comparator
Arm Description
participants received Fosfomycin Tromethamine Granules + Pivmecillinam Hydrochloride Tablets Simulant Fosfomycin Tromethamine Granules:oral, 1 pack, only once for the entire course of treatment. Pivmecillinam Hydrochloride Tablets Simulant :oral,One tablets each time,3 times a day for five days.
Intervention Type
Drug
Intervention Name(s)
Pivmecillinam hydrochloride tablets
Other Intervention Name(s)
Selexid®
Intervention Description
400mg tablet
Intervention Type
Drug
Intervention Name(s)
Fosfomycin Tromethamine Granules
Other Intervention Name(s)
Monurol®
Intervention Description
3g/pack
Primary Outcome Measure Information:
Title
Change in urinary tract infection symptom score
Description
The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms). Change = (Day 12±2 Score - Baseline Score)
Time Frame
From Baseline to Day 12±2
Title
Urine white blood cell count
Description
Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.
Time Frame
Day 12±2
Secondary Outcome Measure Information:
Title
Urine culture pathogen count at visit
Description
The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to< 10^3 CFU(Colony-Forming Unit)/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).
Time Frame
Day 12±2
Title
Change in urinary tract infection symptom score
Description
The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, Urinary pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms). Change = (Day 12±2 Score - Baseline Score)
Time Frame
From Baseline to Day 5+1
Title
Urine white blood cell count
Description
Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.
Time Frame
Day 5+1
Title
Urine culture pathogen count at visit
Description
The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to<10^3 CFU/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).
Time Frame
Day 5+1
Title
Change in urinary tract infection symptom score
Description
The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, Urinary pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms). Change = (Day 12±2 Score - Baseline Score)
Time Frame
From Baseline to Day 21+7
Title
Urine white blood cell count
Description
Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.
Time Frame
Day 21+7
Title
Urine culture pathogen count at visit
Description
The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to<10^3 CFU/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).
Time Frame
Day 21+7
Title
Safety variables
Description
Safety variables: adverse events reported by the patient at the visit or occurred during the trial.
Time Frame
Day 5+1,Day 12±2,Day 21+7

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; Have taken probenecid, metoclopramide, methotrexate, aspirin, or other antimicrobial agents within 48 hours prior to dosing; Have taken valproic acid or valproic acid-releasing drugs (including sodium valproate, sodium divalproex, etc.) within 48 hours prior to dosing; Previous or current STDs; Previous diabetes mellitus with unregulated treatment showing abnormal blood glucose ; Patients allergic (including lactose intolerance) to penicillins, pivmecillinam, mecillinam, cephalosporins, fosfomycin tromethamine, or other components of the study drug; Patients suspected to be unable to comply with the protocol (e.g., alcoholism, drug dependence, or poor mental status); Patients have been enrolled in this trial; Those who have participated in other drug interventional clinical trials or are participating in other clinical trials within 3 months prior to screening; Patients who have taken study drug within the past 3 months; Pregnant, lactating women, patients who are pregnant during the study or have a fertility plan within 3 months after the end of the trial; Complaints of active gastric ulcer and episodes of hemorrhagic gastritis; 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 ; Those who are judged by the investigator to be ineligible for enrollment by clinical laboratory tests, electrocardiograms, urinary ultrasound, etc.; Other reasons for inappropriate participation in the trial in the opinion of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Gao, Master
Phone
18602696542
Email
k.gao@greenpine.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangdong Yang, PhD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Liu
Phone
010-85138105
Email
bjyyec@126.com
First Name & Middle Initial & Last Name & Degree
Jianlong Wang
First Name & Middle Initial & Last Name & Degree
Jianlong* Wang
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TingTing Zhang
Phone
020-62783254
Email
zjyyllxs@126.com
First Name & Middle Initial & Last Name & Degree
Abai Xu
First Name & Middle Initial & Last Name & Degree
Peng Xu
Facility Name
The second hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjuan He
Phone
0311-66002837
Email
HB2HLL@126.com
First Name & Middle Initial & Last Name & Degree
Wei Li
First Name & Middle Initial & Last Name & Degree
Yanping Zhang
Facility Name
Xiangya Humanity Rehabilitation hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bin huang
Facility Name
Loudi Central Hospital
City
Loudi
State/Province
Hunan
ZIP/Postal Code
417000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siwei Li
Phone
0738-8527739
Email
ldszxyyllwyh@163.com
First Name & Middle Initial & Last Name & Degree
Liang Peng
Facility Name
Yueyang people's Hospital
City
Yueyang
State/Province
Hunan
ZIP/Postal Code
414000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lian Li
Phone
0730-8725326
Email
359016671@qq.com
First Name & Middle Initial & Last Name & Degree
Xiangming Yi
First Name & Middle Initial & Last Name & Degree
Quan Wen
Facility Name
Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XiaoJuan Cao
Phone
025-85630192
Email
lunli2015318@163.com
First Name & Middle Initial & Last Name & Degree
Jianjun Yang
First Name & Middle Initial & Last Name & Degree
Xiangnong Hu
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kexin Tian
Phone
0531-82169603;0531-82169135
Email
ec82169603@163.com
First Name & Middle Initial & Last Name & Degree
Xiangdong Yang
First Name & Middle Initial & Last Name & Degree
Xiaoyan Xiao
Facility Name
Yantai Yuhuangding hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KangQi Li
Phone
0535-6229756
Email
yhdirb@163.com
First Name & Middle Initial & Last Name & Degree
Peng li
First Name & Middle Initial & Last Name & Degree
Lina Yang

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection

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