Complicated Urinary Tract Infection Including Acute PyelonephritisPhase 3NCT05204368
Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)
A Phase 3 study testing Combination of Imipenem/Cilastatin and XNW4107 and Meropenem in people with Complicated Urinary Tract Infection Including Acute Pyelonephritis, run by Evopoint Biosciences Inc. at 1 site in United States.
Trial summary
This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with Complicated Urinary Tract Infections, 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 Including Acute Pyelonephritis
- What is being tested?
- Combination of Imipenem/Cilastatin and XNW4107 and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to Dec 2025
- 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
- Patients willing and able to provide written informed consent.
- Willing and able to comply with all study assessments and adhere to the protocol schedule.
- Hospitalized or requiring hospitalization for cUTI or AP in male or female patients ≥18 years on the day of signing informed consent.
- Requiring treatment with IV antibiotic therapy.
- Evidence of AP or cUTI
- At least 1 of the following:
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- Nausea or vomiting.
- Chills or rigors or warmth associated with fever (temperature >38°C).
- Peripheral white blood cell count (WBC) >10,000/mm³ or bandemia , regardless of WBC count.
- Having at least 1 of the following complicated factors for cUTI (not required for AP):
- Indwelling catheter of the urinary tract.
- Urinary retention.
- Any functional or anatomical abnormality of the urogenital tract resulting in at least 100 mL or more of residual urine after voiding.
- Obstructive uropathy .
- Evidence of pyuria demonstrated by 1 of the following methods:
- Dipstick analysis positive for leukocyte esterase.
- ≥10 WBCs per µL in unspun urine, or ≥10 WBCs per high power field in spun urine.
Who cannot join
- Patients with any of the following conditions:
- Suspected or confirmed perinephric abscess
- Suspected or confirmed renal corticomedullary abscess
- Suspected or confirmed acute or chronic bacterial prostatitis, orchitis, or epididymitis, as determined by history and/or physical examination
- Known polycystic kidney disease or only 1 functional kidney
- Known chronic vesicoureteral reflux
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- Previous renal transplantation or planned renal transplantation within 2 weeks of study entry
- Patients receiving renal replacement therapy
- Complete, permanent obstruction of the urinary tract
- Urinary tract symptoms attributable to a sexually transmitted disease.
- Gross hematuria requiring intervention other than administration of study drug.
- Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy).
- Patient has any urinary catheter or device that will not be removed or replaced (if removal is not clinically acceptable) during IV therapy, including but NOT limited to indwelling bladder catheters, ureteral catheters, suprapubic catheters, J stents, and nephrostomy tubes.
- Renal function at Screening as estimated glomerular filtrated rate <15 mL/min/1.73㎡, calculated using Modification of Diet in Renal Disease.
- Known non-urinary tract source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization.
- Any rapidly progressing disease or immediately life-threatening illness, including, but not limited to, current or impending respiratory failure, septic shock, acute heart failure, acute coronary syndrome, unstable arrhythmias, hypertensive emergency, acute hepatic failure, active gastrointestinal bleeding, profound metabolic abnormalities (e.g., diabetic ketoacidosis), or acute cerebrovascular events.
- If the culture result is available prior to randomization and identifies only a Gram-positive pathogen and/or only a Gram negative pathogen (>10^5 CFU/mL) known to be resistant to meropenem
- If the culture result is available prior to randomization and identifies isolates >2 pathogens or no pathogens with >10^5 CFU/mL identified or patient has a confirmed fungal UTI.
- Receipt of more than 24 hours of a potentially effective systemic antibacterials within 72 hours prior to start of study therapy.
- History of a seizure disorder.
- Female patients of childbearing potential, who are unable or unwilling to use a highly effective method of birth control during the study and for at least 30 days following the last dose of study medication.
- A female who is pregnant or breastfeeding, or have a positive pregnancy test at Screening.
- Patient is participating in any clinical study of any investigational medication (i.e., non-licensed medication) during the 30 days prior to randomization. COVID-19 vaccines that are given under emergency use authorization are not considered investigational agents.
- Documented presence of immunodeficiency or an immunocompromised condition including hematologic malignancy, bone marrow transplant, known human immunodeficiency virus infection with a CD4 count <200/mm³, or requiring frequent or prolonged use of systemic corticosteroids or other immunosuppressive drugs.
- Patients with 1 or more of the following laboratory abnormalities in baseline specimens: aspartate aminotransferase, alanine aminotransferase >3 × the upper limit of normal (ULN), total bilirubin level >2 × ULN (except for isolated hyperbilirubinemia due to known Gilbert's disease), neutrophils <500 cells/mm³, platelet count <40,000/mm³
- Patients requires concomitant medication with valproic acid or divalproex.
- History of active liver disease, cirrhosis.
- Documented or severe hypersensitivity or previous severe adverse drug reaction, especially to any beta-lactam antibiotics, or any of the excipients used in the study drug formulations.
- Any other condition or prior therapy, which, in the opinion of the investigator, would make the patient unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
xnwlcyy@evopointbio.com
Kalpana Shere-Wolfe
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis.(EudraCT no. 2022-000061-40)
This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with Complicated Urinary Tract Infections, including Acute Pyelonephritis.
- Being tested
- Combination of Imipenem/Cilastatin and XNW4107, Meropenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Imipenem/Cilastatin and XNW4107Drug
Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for injection
MeropenemDrug
Meropenem 1g for injection
| Study group | Role | What they receive |
|---|---|---|
| Imipenem/Cilastatin/XNW4107 | Experimental | Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg ,q6h(0.5h infusion) Receives: Drug: Combination of Imipenem/Cilastatin and XNW4107 |
| Meropenem | Active comparator | Meropenem 1g ,q8h (0.5h infusion) Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall success
The proportion of patients who achieve overall success at the Test of cure(TOC) visit in the micro-modified-intent-to-treat(micro-MITT) population.
Overall success requires symptomatic clinical success and microbiologic success at the TOC visit.
Measured: Day 21[±2 days]
Secondary outcomes (7)
overall success
The proportion of patients who achieve overall success at the End of treatment (EOT) visit in the micro-MITT population.
Measured: EOT: from treatment day 7 up to day 15
overall success
The proportion of patients who achieve overall success at the Late follow-up(LFU) visit in the micro-MITT, extended micro-MITT, Clinically evaluable(CE), Microbiologically evaluable(ME) populations.
Measured: Day 28[±3 days]
symptomatic clinical success
The proportion of patients with symptomatic clinical success at Day 4, EOT, TOC, and LFU visit in the micro-MITT, extended micro-MITT, CE, and ME populations
Measured: Day 4; EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]
microbiological success
The proportion of patients with microbiological success at EOT, TOC, and LFU visit in the micro-MITT, extended micro-MITT, and ME populations
Measured: EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]
By-pathogen microbiological success
The proportion of patients with by-pathogen microbiological success at EOT, TOC, and LFU visit in the micro-MITT, extended micro-MITT, and ME populations
Measured: EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]
The proportion of overall success; symptomatic clinical, and microbiologic success
The proportion of overall success; symptomatic clinical, and microbiologic success at EOT, TOC, and LFU visit in the Carbapenem-resistant-MITT(CR-MITT) population
Measured: EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]
clinical success
The proportion of patients with clinical success based on the investigator's assessment of clinical response at TOC visit in the micro-MITT population
Measured: Day 21[±2 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start30 Mar 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Urinary Tract Infection Including Acute PyelonephritisStudies of the same condition, open and under way.
- More trials run by Evopoint Biosciences Inc.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
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evopoint Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Le, Study chair, Evopoint Biosciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204368
- Sponsor's protocol ID
- XNW4107-301
- Status last verified
- Feb 2023
- First submitted
- 5 Jan 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis.(EudraCT no. 2022-000061-40)
- ClinicalTrials.gov ID
- NCT05204368
- Acronym / sponsor ID
- XNW4107-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Evopoint Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Jan 2022 (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.
This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with Complicated Urinary Tract Infections, 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 |
|---|---|---|
| Imipenem/Cilastatin/XNW4107 | Experimental | Drug: Combination of Imipenem/Cilastatin and XNW4107Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg ,q6h(0.5h infusion) |
| Meropenem | Active comparator | Drug: MeropenemMeropenem 1g ,q8h (0.5h infusion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients willing and able to provide written informed consent.
- Willing and able to comply with all study assessments and adhere to the protocol schedule.
- Hospitalized or requiring hospitalization for cUTI or AP in male or female patients ≥18 years on the day of signing informed consent.
- Requiring treatment with IV antibiotic therapy.
- Evidence of AP or cUTI
Key exclusion criteria (29 listed)
- Patients with any of the following conditions:
- Gross hematuria requiring intervention other than administration of study drug.
- Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy).
- Patient has any urinary catheter or device that will not be removed or replaced (if removal is not clinically acceptable) during IV therapy, including but NOT limited to indwelling bladder catheters, ureteral catheters, suprapubic catheters, J stents, and nephrostomy tubes.
- Renal function at Screening as estimated glomerular filtrated rate <15 mL/min/1.73㎡, calculated using Modification of Diet in Renal Disease.
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 |
|---|---|---|
| Combination of Imipenem/Cilastatin and XNW4107Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for injection | Drug | Imipenem/Cilastatin/XNW4107 |
| MeropenemMeropenem 1g for injection | Drug | Meropenem |
Primary outcome
overall success
Time frame: Day 21[±2 days]
The proportion of patients who achieve overall success at the Test of cure(TOC) visit in the micro-modified-intent-to-treat(micro-MITT) population. Overall success requires symptomatic clinical success and microbiologic success at the TOC visit.
7 secondary outcomes
overall success
Time frame: EOT: from treatment day 7 up to day 15
overall success
Time frame: Day 28[±3 days]
symptomatic clinical success
Time frame: Day 4; EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]
microbiological success
Time frame: EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]
By-pathogen microbiological success
Time frame: EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]
The proportion of overall success; symptomatic clinical, and microbiologic success
Time frame: EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]
clinical success
Time frame: Day 21[±2 days]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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Acute Pyelonephritis, Complicated Urinary Tract Infection
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.
Jason Le study chair
Evopoint Biosciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination of Imipenem/Cilastatin and XNW4107 and Meropenem in people with Complicated Urinary Tract Infection Including Acute Pyelonephritis, run by Evopoint Biosciences Inc. at 1 site in United States.
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 17 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Pan (+86 0512-89162086, xnwlcyy@evopointbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall success (time frame: Day 21[±2 days]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2023.