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

Uncomplicated Urinary Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05545137
• Other study ID #: CS1046
• Status: Completed
• Phase: Phase 3
• Start date: September 29, 2022
• Est. completion date: February 20, 2024

Study information

• Verified date: April 2024
• Source: Greenpine Pharma Group Co., ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: February 20, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Uncomplicated Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Pivmecillinam hydrochloride tablets
400mg tablet
• Fosfomycin Tromethamine Granules
3g/pack

Locations

Country	Name	City	State
China	Beijing hospital	Beijing	Beijing
China	Xiangya Humanity Rehabilitation hospital	Changsha	Hunan
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Loudi Central Hospital	Loudi	Hunan
China	Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine	Nanjing	Jiangsu
China	Guangxi Zhuang Autonomous Region People's Hospital	Nanning	Guangxi
China	The second hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Wuhan Central Hospital	Wuhan	Hubei
China	Yueyang people's Hospital	Yueyang	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Benova (Tianjin) Innovative medicine Research Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From Baseline to Day 12±2
Primary	Urine white blood cell count	Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.	Day 12±2
Secondary	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).	Day 12±2
Secondary	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)	From Baseline to Day 5+1
Secondary	Urine white blood cell count	Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.	Day 5+1
Secondary	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).	Day 5+1
Secondary	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)	From Baseline to Day 21+7
Secondary	Urine white blood cell count	Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.	Day 21+7
Secondary	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).	Day 21+7
Secondary	Safety variables	Safety variables: adverse events reported by the patient at the visit or occurred during the trial.	Day 5+1,Day 12±2,Day 21+7