- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06144060
A Trial of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute Pyelonephritis
November 16, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Multi-center, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase II Study to Evaluate the Efficacy and Safety of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute Pyelonephritis
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
126
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaopeng Wang
- Phone Number: +86-182-6038-7118
- Email: xiaopeng.wang@hengrui.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- A QTcF interval prolongation at screening or abnormalities with clinical significance and may cause obvious safety risk to the subjects;
- Known urine culture with at least one Gram-Negative uropathogen at ≥105 colony-forming units(CFU)/mL unsusceptible to Imipenem and Cilastatin Sodium, or only identify Gram-positive uropathogen, or confirmed fungal urinary tract infection with ≥103CFU/mL;
- Indwelling catheter or urinary tract instrument, in the opinion of the Investigator, incapable of removal during the study period;
- Likely to require the use of antibiotic for cUTI or AP prophylaxis after treatment;
- Suspected of sepsis, producing life-threatening organ dysfunction;
- Estimated survival within 6 weeks or rapidly progressive or end stage disease with high mortality rate;
- Drug abuse prior to the randomization;
- Participated in, any other clinical study involving the administration of active investigational or experimental medication prior to the randomization, or 5 half-lives, whichever is longer, prior to Screening;
- In the judgment of the Investigator, other reasons unsuitable for study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group A:HRS-8427
|
The dose and frequency of administration were adjusted according to the eGFR.
|
Experimental: Treatment group B:HRS-8427
|
The dose and frequency of administration were adjusted according to the eGFR.
|
Active Comparator: Imipenem and Cilastatin Sodium
|
The dose and frequency of administration were adjusted according to the eGFR .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC)
Time Frame: Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)
|
Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
Time Frame: EA : Day 4、EOT: Day 7 to Day 14、LFU:Day 21 to Day 28
|
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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2023
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
November 16, 2023
First Submitted That Met QC Criteria
November 16, 2023
First Posted (Actual)
November 22, 2023
Study Record Updates
Last Update Posted (Actual)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Nephritis
- Nephritis, Interstitial
- Pyelitis
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Infections
- Communicable Diseases
- Urinary Tract Infections
- Pyelonephritis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Anti-Bacterial Agents
- Imipenem
- Cilastatin
- Cilastatin, Imipenem Drug Combination
Other Study ID Numbers
- HRS-8427-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
-
PfizerForest LaboratoriesCompletedComplicated Urinary Tract Infection (cUTI) Including Acute PyelonephritisCroatia, Brazil, Bulgaria, Korea, Republic of, Russian Federation, Hungary, Poland, Romania, Ukraine, Argentina, Israel, Portugal, Greece, Taiwan, Japan, Slovakia, Serbia, United States, Mexico, Germany, Turkey, Czechia
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PfizerForest LaboratoriesCompletedComplicated Urinary Tract Infection (cUTI) Including Acute PyelonephritisCroatia, Bulgaria, Korea, Republic of, Mexico, Peru, Poland, Russian Federation, Spain, Romania, Ukraine, United States, Argentina, Czechia, Israel, Taiwan, Germany, Italy
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Nabriva Therapeutics AGMedpace, Inc.CompletedAcute Pyelonephritis | Urinary Tract Infection Complicated | Urinary Tract Infection SymptomaticPoland, Ukraine, Belarus, Bulgaria, Romania, Greece, United States, Russian Federation, Hungary, Lithuania, Slovakia, Czechia, Latvia, Croatia, Georgia, Estonia
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Venus Remedies LimitedCompletedAcute Pyelonephritis | Urinary Tract Infection ComplicatedIndia
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