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Beta-lactam antibiotics
Imipenem/Cilastatin/XNW4107 vs Meropenem for Urinary Tract Infection
Phase 3
Waitlist Available
Research Sponsored by Sinovent Pty Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of AP or cUTI
Requiring treatment with IV antibiotic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 4; eot: from treatment day 7 up to day 15; toc: day 21[±2 days]; lfu: day 28[±3 days]
Awards & highlights
Study Summary
This trial compares two antibiotics to treat complicated urinary tract infections in adults, measuring safety and effectiveness.
Who is the study for?
Adults hospitalized or needing hospitalization for complicated urinary tract infections (cUTI) or acute pyelonephritis (AP), who are willing to follow study procedures and can give informed consent. Excluded are those with certain abscesses, one functional kidney, severe non-urinary infections, recent surgery, poor renal function, known drug allergies, immunodeficiency conditions, or on disallowed treatments.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of a new antibiotic combination (Imipenem/Cilastatin/XNW4107) versus Meropenem in treating cUTI including AP. It's a phase 3 study where participants are randomly assigned to either treatment group in a double-blind manner.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to antibiotics such as rashes or itching; gastrointestinal issues like nausea or diarrhea; possible liver enzyme changes; and risk of seizures especially for those with seizure disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a complicated urinary tract infection or acute pyelonephritis.
Select...
I need treatment with antibiotics through an IV.
Select...
I am 18 or older and in the hospital for a complicated urinary tract infection or acute pyelonephritis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 4; eot: from treatment day 7 up to day 15; toc: day 21[±2 days]; lfu: day 28[±3 days]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4; eot: from treatment day 7 up to day 15; toc: day 21[±2 days]; lfu: day 28[±3 days]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
By-pathogen microbiological success
The proportion of overall success; symptomatic clinical, and microbiologic success
clinical success
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Imipenem/Cilastatin/XNW4107Experimental Treatment1 Intervention
Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg ,q6h(0.5h infusion)
Group II: MeropenemActive Control1 Intervention
Meropenem 1g ,q8h (0.5h infusion)
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Who is running the clinical trial?
Sinovent Pty Ltd.Lead Sponsor
7 Previous Clinical Trials
707 Total Patients Enrolled
Evopoint Biosciences Inc.Lead Sponsor
8 Previous Clinical Trials
911 Total Patients Enrolled
Jason LeStudy ChairEvopoint Biosciences Inc.
4 Previous Clinical Trials
622 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong antibiotics for more than a day within the last 3 days.I am on dialysis.I have urinary symptoms caused by an STD.I have a history of seizures.I have been diagnosed with a serious infection other than in the urinary tract within the last week.My urinary tract is completely and permanently blocked.I am a woman able to have children and will not use birth control during the study.I have a long-term condition where urine flows back to my kidneys.I have severe blood in my urine needing treatment beyond study medication.You have certain abnormal test results before starting the study.I need to take valproic acid or divalproex for my condition.I have a complicated urinary tract infection or acute pyelonephritis.I need treatment with antibiotics through an IV.You have at least one of the specific health issues related to complicated urinary tract infections.I am 18 or older and in the hospital for a complicated urinary tract infection or acute pyelonephritis.My infection is caused by bacteria resistant to meropenem.There is evidence of pyuria shown by one of the following methods.My kidney function is very low, as measured by a specific test.I have had a kidney transplant or will have one within 2 weeks.I am not pregnant, breastfeeding, or have a positive pregnancy test.If the test shows that there are more than two types of germs, or no germs with a high amount, or if you have a confirmed fungal urinary tract infection.I haven't had recent urinary tract surgery nor plan to during the study, except for obstruction relief.My condition is worsening quickly and threatens my life.I have or might have a kidney abscess.I have or might have an infection in my prostate, testicle, or epididymis.I have or might have an abscess near my kidney.I have polycystic kidney disease or only one working kidney.I have a history of serious liver disease.You have a serious allergy or had a bad reaction to certain antibiotics or other ingredients in the study drug.I have a weak immune system due to a condition like HIV, cancer, or I'm on long-term steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Imipenem/Cilastatin/XNW4107
- Group 2: Meropenem
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Imipenem/Cilastatin/XNW4107 regarded as a safe medication for use by individuals?
"Our experts at Power rate the safety of Imipenem/Cilastatin/XNW4107 as a 3 due to its current position in Phase 3 clinical trials. This indicates that there is prior data confirming efficacy and multiple rounds of studies proving safety."
Answered by AI
Are there any available positions in this research trial for participants?
"As confirmed by clinicaltrials.gov, this research endeavour is no longer recruiting patients. It was initially posted on March 30th 2023 and the last update occurred February 15th 2023. Nevertheless, there are 780 other trials in search of participants at present time."
Answered by AI
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