A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

NCT06569056 | Recruiting Phase 3

• 1 other identifier: HRS-8427-302
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of HRS-8427 in patients with complicated urinary tract infection, including acute pyelonephritis.

Conditions

Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC)

  Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)

Secondary Outcomes (6)

• Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Early Assessment（EA）、End of Treatment（EOT）and Late Follow-Up (LFU)

  EA : Day 4、EOT: Day 7 to Day 14、LFU：Day 21 to Day 28

• Percentage of Participants With Microbiological Eradication at EA 、EOT、TOC and LFU

  EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28

• Percentage of Participants With Microbiological Eradication at EA 、EOT、TOC and LFU Per Uropathogen

  EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28

• Percentage of Participants With Clinical Response at EA 、EOT、TOC and LFU

  EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28

• Percentage of Participants With Clinical Response at EA 、EOT、TOC and LFU Per Uropathogen

  EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28

Study Arms (2)

HRS-8427; Imipenem and Cilastatin Sodium placebo

EXPERIMENTAL

Drug: HRS-8427; Drug: Imipenem and Cilastatin Sodium placebo

Imipenem and Cilastatin Sodium; HRS-8427 placebo

ACTIVE COMPARATOR

Drug: Imipenem and Cilastatin Sodium; Drug: HRS-8427 placebo

Interventions

HRS-8427 DRUG

Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses

HRS-8427; Imipenem and Cilastatin Sodium placebo

Imipenem and Cilastatin Sodium DRUG

Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses

Imipenem and Cilastatin Sodium; HRS-8427 placebo

HRS-8427 placebo DRUG

Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses

Imipenem and Cilastatin Sodium; HRS-8427 placebo

Imipenem and Cilastatin Sodium placebo DRUG

Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses

HRS-8427; Imipenem and Cilastatin Sodium placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent before the study, fully understand the study and be able to complete the study according to the protocol;
• Male and female, ≥18 years;
• Judged by the investigator, clinical diagnosis with cUTI or AP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics;
• Urine specimen with evidence of pyuria；
• Have urine culture specimen obtained within 48 hours prior to randomization;
• hours before random, allowing a short course of antimicrobial drug treatment is less than 24 hours (random rate ≤25%)
• Women of childbearing potential must have a negative serum pregnancy test before first dose, must be non-lactating. Fertile female subjects or male subjects whose partner is a fertile female agree to use highly effective form of contraception, with no plan of birth, sperm/ovum donation from the time of signed ICF till 14 days after end of treatment.

You may not qualify if:

• History of significant hypersensitivity or allergic reaction to any β-lactam, or any β-lactamase inhibitors;
• Known history of immune deficiency disease or receive immunocompromising treatment;
• Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable condition or uncontrolled;
• Known or suspected central nervous system disorder or other factors that may predispose to seizures or lower the seizures onset threshold;
• Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy;
• Uncomplicated lower urinary tract infection;
• Suspected or confirmed urinary tract symptoms caused by acute/chronic prostatitis, orchitis, epididymitis or sexually transmitted diseases as determined by medical history and/or physical examination;
• Patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period;
• Systemic antimicrobial therapy other than the investigational drug need to be used during the study period, with the exception of topical or single oral dose of antifungal treatment
• Urinary tract surgery prior to 7 days before randomization or surgery planned during the study period;
• Indwelling catheter or urinary apparatus, the researchers determine drug treatment period cannot be removed;
• Receipt of potentially effective systemic antibacterial therapy for a continuous duration of ≥24 hours during the previous 48 hours prior to the randomization;
• History of pelvis or urinary tract trauma prior to the randomization;
• Patients had severe trauma or received major surgery prior to the randomization;
• Impairment of renal function with estimated glomerular filtration rate or Creatinine Clearance \<15 mL/min ;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Interventions

Cilastatin, Imipenem Drug Combination; Imipenem

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Xiaopeng Wang

CONTACT

+0518-81220121; xiaopeng.wang@hengrui.com

Jing Xu

CONTACT

+021-23511999; jing.xu.jx23@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 23, 2024
• Study Start: September 25, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-10

Locations

CN (1)