Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)Phase 3NCT06569056

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

A Phase 3 study testing HRS-8427 and Imipenem and Cilastatin Sodium in people with Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP), run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
What is being tested?: HRS-8427 and Imipenem and Cilastatin Sodium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 579 participants
Where: 1 siteChina
Study dates: 25 Sep 2024to 1 Sep 2026
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
48 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.

Who cannot join

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;

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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 ;
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;
Likely to require the use of antibiotic drug prevention 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 a previous clinical study related to HRS-8427 and used HRS-8427 or have participated in another clinical study within 4 weeks before randomization and used a study drug containing the active ingredient;
Judgment of the Investigator, other reasons unsuitable for study.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase III Study to Evaluate the Efficacy and Safety of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

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)
Being tested: HRS-8427, Imipenem and Cilastatin Sodium, HRS-8427 placebo, Imipenem and Cilastatin Sodium placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-8427Drug
Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses
Imipenem and Cilastatin SodiumDrug
Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses
HRS-8427 placeboDrug
Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses
Imipenem and Cilastatin Sodium placeboDrug
Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses

Study groups in NCT06569056
Study group	Role	What they receive
HRS-8427; Imipenem and Cilastatin Sodium placebo	Experimental	Not described Receives: Drug: HRS-8427; Drug: Imipenem and Cilastatin Sodium placebo
Imipenem and Cilastatin Sodium; HRS-8427 placebo	Active comparator	Not described Receives: Drug: Imipenem and Cilastatin Sodium; Drug: HRS-8427 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28
Number of Participants With Adverse Events
Measured: Day 21 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 20241 Sep 2026

First posted23 Aug 2024
Study start25 Sep 2024
Primary completion1 Sep 2026
Study completion1 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)Studies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 579 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06569056
Sponsor's protocol ID: HRS-8427-302
Status last verified: Sep 2026
First submitted: 22 Aug 2024
Last updated: 30 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Yin T, Qu B, Zhang Q, Xu S, Wu Y, Jiang H, Huang Y, Hu W. Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. Antimicrob Agents Chemother. 2026 Apr;70(4):e0069425. doi: 10.1128/aac.00694-25. Epub 2026 Mar 3.
PubMed 41773934
Wu Y, Han Q, Yang H, Xue J, Wang L, Mao X, Yin T, Jiang H, Xu S, Huang Y, Wang T, He Y, Luo Y, Chen W, Zhang J. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0109525. doi: 10.1128/aac.01095-25. Epub 2026 Jan 13.
PubMed 41528248
Cao Y, Huang Y, Xie J, Wu Q, Yang S, Yang X, Huang J, Liu J, Meng J, Yang G. Intrapulmonary penetration and pharmacokinetics of siderophore cephalosporin HRS-8427 injection in Chinese healthy subjects. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0070225. doi: 10.1128/aac.00702-25. Epub 2025 Nov 6.
PubMed 41196282

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase III Study to Evaluate the Efficacy and Safety of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
ClinicalTrials.gov ID: NCT06569056
Acronym / sponsor ID: HRS-8427-302
Conditions: Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 579 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Sep 2024 (actual)
Primary completion: 1 Sep 2026 (actual)
Study completion: 1 Sep 2026 (actual)
First posted: 23 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (24 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS-8427Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses	Drug	HRS-8427; Imipenem and Cilastatin Sodium placebo
Imipenem and Cilastatin SodiumDosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses	Drug	Imipenem and Cilastatin Sodium; HRS-8427 placebo
HRS-8427 placeboDosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses	Drug	Imipenem and Cilastatin Sodium; HRS-8427 placebo
Imipenem and Cilastatin Sodium placeboDosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses	Drug	HRS-8427; Imipenem and Cilastatin Sodium placebo

Primary outcome

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)

6 secondary outcomes

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
Percentage of Participants With Microbiological Eradication at EA 、EOT、TOC and LFU
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28
Number of Participants With Adverse Events
Time frame: Day 21 to Day 28

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Derived from this study: PubMed 41773934Yin T, Qu B, Zhang Q, Xu S, Wu Y, Jiang H, Huang Y, Hu W. Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. Antimicrob Agents Chemother. 2026 Apr;70(4):e0069425. doi: 10.1128/aac.00694-25. Epub 2026 Mar 3.
Derived from this study: PubMed 41528248Wu Y, Han Q, Yang H, Xue J, Wang L, Mao X, Yin T, Jiang H, Xu S, Huang Y, Wang T, He Y, Luo Y, Chen W, Zhang J. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0109525. doi: 10.1128/aac.01095-25. Epub 2026 Jan 13.
Derived from this study: PubMed 41196282Cao Y, Huang Y, Xie J, Wu Q, Yang S, Yang X, Huang J, Liu J, Meng J, Yang G. Intrapulmonary penetration and pharmacokinetics of siderophore cephalosporin HRS-8427 injection in Chinese healthy subjects. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0070225. doi: 10.1128/aac.00702-25. Epub 2025 Nov 6.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06569056, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.