Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
This research study is looking into a new treatment called Rhu-pGSN for a serious lung condition called Acute Respiratory Distress Syndrome (ARDS). ARDS makes it very hard to breathe and can be caused by severe infections like pneumonia. We want to find out if Rhu-pGSN, when given alongside usual hospital care, can help people with moderate to severe ARDS get better and be safer compared to a dummy treatment (placebo). Participants will be randomly assigned to receive either the new medicine or the placebo. The study aims to recruit people who have recently developed ARDS from an infection and are showing significant breathing difficulties.
At a glance
What is this study about?
This study is exploring a new medicine called Rhu-pGSN for a serious lung condition known as Acute Respiratory Distress Syndrome, or ARDS. ARDS can happen when your body reacts very strongly to a severe infection, such as pneumonia, causing your lungs to become inflamed and fill with fluid. This makes it extremely difficult to get enough oxygen, sometimes requiring a breathing machine or other advanced support.
The main goal of this study is to see if Rhu-pGSN can help people with moderate to severe ARDS recover better and more safely than they would with standard hospital care alone. You might be asked to join if you have been recently hospitalised with pneumonia or another infection and have just developed ARDS. The researchers are keen to identify suitable patients within 24 hours of their ARDS diagnosis to give the treatment as early as possible.
Participants will be placed into one of two groups by chance (like flipping a coin). One group will receive Rhu-pGSN, and the other will receive a dummy treatment (called a placebo). Neither you nor your doctors will know which treatment you are receiving – this is called a 'double-blind' study and helps ensure the results are accurate. We hope to learn if Rhu-pGSN can make a real difference for people facing this challenging condition.
Key takeaways
- This study is for adults with severe breathing problems (ARDS) caused by infections.
- It tests a new medicine called Rhu-pGSN against a dummy treatment (placebo).
- Participation involves receiving the study treatment and closely monitoring your health.
- Your medical information will be kept private.
- You can leave the study at any time without any impact on your ongoing care.
Who may be eligible?
This study is looking for adults aged 18 or over who have been hospitalised and recently developed moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to an infection. This means your lungs are struggling significantly, and you likely need help with your breathing, such as a breathing machine, a special face mask, or high-flow oxygen.
You would need to have clear signs of ARDS on a chest X-ray or scan that appeared within the last week. The breathing difficulties need to have started within the last 48 hours to be considered for the study. The doctors also need to be clear that your ARDS was triggered by an infection within the past seven days.
For women who could become pregnant, you would need to agree to use two reliable forms of contraception. Men whose partners could become pregnant would also need to agree to use effective birth control or other preventative measures. These steps are important to ensure safety during the study. If you meet these main points, the medical team will do further checks to see if this study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you recently been diagnosed with moderate to severe ARDS due to an infection?
- Did your ARDS symptoms appear within the last 48 hours?
- Do you have clear signs of ARDS on a recent chest X-ray or scan?
- Are you able to use reliable contraception if you or your partner could become pregnant?
What does participation involve?
If you decide to take part in this study, the first step is to give your informed consent, which means you understand what's involved and agree to participate. Once consented, the medical team will confirm your eligibility based on your breathing difficulties and medical history. They will record information about any medicines you are currently taking and, if you are a woman who could become pregnant, you will have a pregnancy test.
You will then receive either the new study medicine, Rhu-pGSN, or a placebo (a dummy treatment) through a drip. Neither you nor your doctors will know which one you are getting. Throughout the study, the medical team will closely monitor your health and recovery, performing regular checks and assessments as part of your ongoing hospital care.
The study will follow your progress during your hospital stay and for at least three months after you receive your last dose of the study treatment. This helps us understand the long-term effects of the medicine. The exact number of assessments and the total duration will depend on your hospital stay and recovery.
Potential risks and benefits
Locations (76)
- University of California Irvine Medical CenterVerified postcodeIrvine, United States· Recruiting
- Cedars-Sinai Medical CenterVerified postcodeLos Angeles, United States· Recruiting
- Wellstar MCG Augusta UniversityVerified postcodeAugusta, United States· Recruiting
- Northwestern University - Pulmonary and Critical Care MedicineVerified postcodeChicago, United States· Recruiting
- University of Louisville Hospital - Jewish HospitalVerified postcodeLouisville, United States· Recruiting
- University of Louisville-Jewish HospitalVerified postcodeLouisville, United States· Recruiting
- Mayo ClinicVerified postcodeRochester, United States· Recruiting
- Hannibal Regional HospitalVerified postcodeHannibal, United States· Recruiting
- Bryan Medical CenterVerified postcodeLincoln, United States· Recruiting
- New York University Grossman School of MedicineVerified postcodeNew York, United States· Not yet recruiting
- Penn State Health - Milton S. Hershey Medical CenterVerified postcodeHershey, United States· Recruiting
- Penn State Health - Milton S. Hershey Medical CenterVerified postcodeHershey, United States· Recruiting
Common questions
What is ARDS?
ARDS (Acute Respiratory Distress Syndrome) is a serious lung condition where your lungs become very inflamed and struggle to get enough oxygen into your blood, often requiring a breathing machine.
What is Rhu-pGSN?
Rhu-pGSN is a new experimental medicine being tested to see if it can help people with ARDS caused by infections.
Will I get the new medicine or a dummy treatment?
You will be randomly assigned to receive either Rhu-pGSN or a dummy treatment (placebo). Neither you nor your doctors will know which one you are getting during the study.
How long will I be in the study?
You will be monitored during your hospital stay and for at least three months after your last dose of the study treatment.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time without it affecting your medical care.
How to find out more
Howard Levy, MD PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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