BridgeMD
New treatment option for Complicated Urinary Tract Infection(cUTI), Including Acute...
Official title A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
ClinicalTrials.gov ID: NCT06569056
What this study is testing
What is HRS-8427?
HRS-8427 is an investigational medicine, being studied as a potential treatment for complicated urinary tract infection(cuti), including acute pyelonephritis(ap).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Urine specimen with evidence of pyuria；
- Have urine culture specimen obtained within 48 hours prior to randomization;
You likely can't join 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 how well it works;
- Uncomplicated lower urinary tract infection;
See the full eligibility 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 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 people or male people whose partner is a fertile female agree to use highly effective...
- 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 how well it works;
- 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 ;
- 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 people;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.