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

NCT06144060 | Unknown Phase 2

• 1 other identifier: HRS-8427-202
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Patients With 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 (5)

• 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（Day 4） 、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）

  EA（Day 4） 、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）

• Percentage of Participants With Microbiological Eradication at EA （Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment） Per Uropathogen

  EA （Day 4）、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment） Per Uropathogen

• Percentage of Participants With Clinical Response at EA（Day 4） 、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）

  EA（Day 4） 、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU（14 days after end of treatment）

• Percentage of Participants With Clinical Response at EA（Day 4） 、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU （14 days after end of treatment）Per Uropathogen

  EA（Day 4） 、EOT（End of treatment）、TOC（7 days after end of treatment） and LFU （14 days after end of treatment）Per Uropathogen

Study Arms (3)

Treatment group A：HRS-8427

EXPERIMENTAL

Drug: HRS -8427

Treatment group B：HRS-8427

EXPERIMENTAL

Drug: HRS -8427

Imipenem and Cilastatin Sodium

ACTIVE COMPARATOR

Drug: Imipenem and Cilastatin Sodium

Interventions

HRS -8427 DRUG

The dose and frequency of administration were adjusted according to the eGFR.

Treatment group A：HRS-8427; Treatment group B：HRS-8427

Imipenem and Cilastatin Sodium DRUG

The dose and frequency of administration were adjusted according to the eGFR .

Imipenem and Cilastatin Sodium

Eligibility Criteria

• Age: 18 Years - 75 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 to 75 years of age, inclusive;
• 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;
• 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 diagnosed malignant tumors prior to randomization and currently with;
• 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 the randomization or urinary tract surgery planned during the study period;
• Receipt of potentially effective systemic antibacterial therapy for a continuous duration of \>24 hours during the previous 72 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, or surgery planned during the study period;
• Impairment of renal function with estimated glomerular filtration rate \<15 mL/min (calculated by the Modification of Diet in Renal Disease study equation);
• Laboratory abnormalities in baseline specimens obtained at screening;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Interventions

Cilastatin, Imipenem Drug Combination

Intervention Hierarchy (Ancestors)

Imipenem; 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

+86-182-6038-7118; xiaopeng.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: November 16, 2023
• First Posted: November 22, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11