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Drug Combinations for Bacterial Pneumonia (REITAB-2 Trial)
Phase 3
Recruiting
Research Sponsored by Sinovent Pty Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fulfills clinical criteria with symptoms or signs of cough, expectorated sputum production, dyspnea, worsening oxygenation, increase in respiratory secretions, fever/ hypothermia
Be older than 18 years old
Must not have
Have HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction
Patients in refractory septic shock
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at late follow-up (lfu), up to 31 days
Awards & highlights
Summary
This trial is testing two antibiotic combinations to treat severe lung infections acquired in hospitals or through ventilators. The antibiotics work by breaking down the bacteria's protective walls, helping to clear the infection.
Who is the study for?
This trial is for adults with hospital-acquired or ventilator-associated bacterial pneumonia who need IV antibiotics. They must have symptoms like cough, fever, and changes on chest X-rays suggestive of pneumonia. Women of childbearing age and men with partners must agree to use birth control during the study.
What is being tested?
The study compares two antibiotic treatments for bacterial pneumonia: Imipenem/Cilastatin combined with XNW4107 versus Imipenem/Cilastatin/Relebactam. The goal is to see if the first combination is just as effective in reducing death rates as the second.
What are the potential side effects?
Possible side effects include allergic reactions, gastrointestinal issues (like diarrhea), blood abnormalities, potential kidney or liver problems, and seizures in those at risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms like coughing, difficulty breathing, or fever.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a lung infection due to blockage, possibly from lung cancer.
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I am in a severe, unresponsive state of septic shock.
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My kidney function is very low.
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I am currently on dialysis.
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I am not pregnant, breastfeeding, or have a positive pregnancy test.
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I have an infection in my brain or spinal cord.
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I am expected to be treated with specific medications for a lung infection.
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I have a history of liver disease or cirrhosis.
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I have or might have pneumonia, including from COVID-19 or chemicals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at late follow-up (lfu), up to 31 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at late follow-up (lfu), up to 31 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Day 14 all-cause mortality rate
Secondary study objectives
Day 28 all-cause mortality rate
The proportion of subjects with clinical success at Day 4
The proportion of subjects with clinical success at EOT
+5 moreOther study objectives
Number of days in intensive care unit (ICU)
Number of days on a ventilator and ventilator free days
Total number of days in hospital
Trial 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: Imipenem/Cilastatin/RelebactamActive Control1 Intervention
Imipenem/Cilastatin/Relebactam 1.25g Q6h (0.5h Infusion)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for bacterial pneumonia, such as the combination of imipenem, cilastatin, and potentially a beta-lactamase inhibitor like XNW4107, work by targeting bacterial cell wall synthesis and protecting the antibiotic from degradation. Imipenem inhibits cell wall synthesis, leading to bacterial death, while cilastatin prevents its breakdown in the kidneys, enhancing its efficacy.
A beta-lactamase inhibitor would further protect imipenem from bacterial enzymes that confer resistance. This multi-faceted approach is essential for effectively treating bacterial pneumonia, especially in the presence of resistant bacterial strains.
[Clinical evaluation of imipenem/cilastatin sodium in the internal medicine].Successful management of multidrug-resistant Pseudomonas aeruginosa pneumonia after kidney transplantation in a dog.
[Clinical evaluation of imipenem/cilastatin sodium in the internal medicine].Successful management of multidrug-resistant Pseudomonas aeruginosa pneumonia after kidney transplantation in a dog.
Find a Location
Who is running the clinical trial?
Sinovent Pty Ltd.Lead Sponsor
7 Previous Clinical Trials
1,037 Total Patients Enrolled
Evopoint Biosciences Inc.Lead Sponsor
9 Previous Clinical Trials
1,417 Total Patients Enrolled
Jason LeStudy ChairEvopoint Biosciences USA, Inc.)
4 Previous Clinical Trials
952 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for less than 3 days.I have been treated with antibiotics for a lung infection for more than 24 hours in the last 3 days.You have abnormal test results in your blood samples taken before the study starts.I have a lung infection needing IV antibiotics, starting after hospital stay or ventilation.I am currently on or have been on seizure medication in the past 3 years.I have symptoms like coughing, difficulty breathing, or fever.You had a severe allergic reaction to beta-lactam antibiotics or any ingredients in the study drug.You have high levels of white blood cells or immature neutrophils in your laboratory tests.I have a lung infection due to blockage, possibly from lung cancer.I am in a severe, unresponsive state of septic shock.Your APACHE II score is higher than 30.My kidney function is very low.The test of your respiratory sample only shows a certain type of bacteria called Gram-positive cocci.You have new or worsening signs of bacterial pneumonia in your chest X-ray or CT scan.I am currently on dialysis.I am not pregnant, breastfeeding, or have a positive pregnancy test.You have a documented weak immune system or immune system condition.I have an infection in my brain or spinal cord.I am expected to be treated with specific medications for a lung infection.I have a history of liver disease or cirrhosis.I am willing to use birth control during and after the study.I have or might have pneumonia, including from COVID-19 or chemicals.
Research Study Groups:
This trial has the following groups:- Group 1: Imipenem/Cilastatin/Relebactam
- Group 2: Imipenem/Cilastatin/XNW4107
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- 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.
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