UnknownPhase 2

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

126 participantsStarted 2023-12

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

What they're measuring

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

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

Trial details

NCT IDNCT06144060

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06

Contact for this trial

Xiaopeng Wang

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

View on ClinicalTrials.gov More Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP) trials