Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL
Doctors are studying whether a medicine called acyclovir can help people who are very ill in intensive care. These patients have pneumonia (a serious lung infection) and also have the herpes simplex virus (HSV) in their lungs. Most people carry HSV, which usually just causes cold sores when they're run down. However, in very sick patients on breathing machines, this virus can become active in the lungs. It's not clear if treating this virus helps these patients get better or if the medicine might cause problems. This study will give some patients acyclovir and others nothing, to see if the medicine improves their chances of survival and recovery. This will help doctors understand the best way to treat these patients.
At a glance
What is this study about?
Imagine you're very, very poorly in intensive care, needing a machine to help you breathe because of a serious lung infection called pneumonia. It turns out that about half of seriously ill patients like this also have the herpes simplex virus (HSV) active in their lungs. HSV is the same virus that causes cold sores, and most people carry it without it causing problems most of the time. When you're extremely unwell and stressed, like in intensive care, this virus can wake up.
Doctors aren't sure whether this active virus in the lungs is just a sign of how sick someone is, or if it's actually making them worse and needs treating. Currently, some doctors choose to treat it with an antiviral medicine called acyclovir, while others don't. Previous studies have hinted that treating the virus might help patients survive more often, but these studies weren't clear enough to say for sure because they didn't directly compare people receiving treatment to those who didn't.
This new study aims to finally get a clear answer. Patients who meet certain criteria will be randomly assigned to one of two groups: one group will receive acyclovir, and the other will not. Doctors will then carefully watch to see which group recovers better and survives more often. The main goal is to find out if giving acyclovir helps these very ill patients recover and survive, providing important information for how to treat similar patients in the future.
Key takeaways
- This study investigates treating herpes virus in critically ill pneumonia patients.
- It aims to see if acyclovir improves survival in patients on breathing machines.
- Patients will be randomly assigned to receive acyclovir or no antiviral medicine.
- The study seeks to clarify best treatment practices for these patients.
- Participation involves monitoring for 30 days and potential acyclovir treatment for up to 10 days.
- The findings will help doctors make better decisions about care.
Who may be eligible?
This study is for adults aged 18 or over who are currently in intensive care and need help with their breathing (either with a machine or another type of support). They must also have pneumonia and have the herpes simplex virus (HSV) detected in their lungs, specifically with a certain amount of the virus present. Patients or their legal representatives will need to agree to take part.
There are several reasons why someone might not be able to join. These include having an allergic reaction to acyclovir in the past, or currently being pregnant or breastfeeding. Also, if a patient is already in another medical study or if doctors have decided to stop life-sustaining treatments, they wouldn’t be able to participate.
Furthermore, patients who are already taking medication for herpes viruses, have had an organ or stem cell transplant, or have very low levels of certain white blood cells (a condition called neutropenia) cannot join. If a patient has taken part in a previous study with the name 'HerpMV', they also won't be eligible.
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?
- Are you in intensive care and need help breathing?
- Do you have pneumonia and the herpes simplex virus in your lungs?
- Have you *not* had an allergic reaction to acyclovir or similar medicines?
- Are you *not* currently taking other herpes antiviral medicines?
- Are you *not* pregnant or breastfeeding, and don't have certain other serious health problems?
What does participation involve?
If you or your loved one joins this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive the study medicine, acyclovir, which is given into a vein. The other group will not receive this specific antiviral medicine. The acyclovir would be given for up to 10 days, or until the patient leaves the intensive care unit, whichever happens first. Doctors and nurses will continue with all other necessary care for both groups.
The study team will closely monitor the patient's health and record information about their recovery, how long they need breathing support, and if their kidney function changes. The main thing they'll look at is how well patients survive within 30 days of joining the study. There will also be checks on general safety. The total duration of active study treatment is up to 10 days, with follow-up on outcomes for 30 days.
Potential risks and benefits
Locations (28)
- Universitätsklinikum FreiburgVerified postcodeFreiburg im Breisgau, Germany· Recruiting
- Universitätsklinikum HeidelbergVerified postcodeHeidelberg, Germany· Recruiting
- Universitätsklinikum HeidelbergVerified postcodeHeidelberg, Germany· Recruiting
- Universitätsklinikum TübingenVerified postcodeTübingen, Germany· Recruiting
- Universitätsklinikum AugsburgVerified postcodeAugsburg, Germany· Recruiting
- Klinikum der Ludwig-Maximilian-Universität MünchenVerified postcodeMünchen, Germany· Recruiting
- Klinikum rechts der IsarVerified postcodeMünchen, Germany· Recruiting
- Klinikum rechts der IsarVerified postcodeMünchen, Germany· Recruiting
- Klinikum Nürnberg, Campus NordVerified postcodeNuremberg, Germany· Recruiting
- Klinikum Nürnberg, Campus SüdVerified postcodeNuremberg, Germany· Recruiting
- Universitätsklinikum RegensburgVerified postcodeRegensburg, Germany· Recruiting
- RoMed Klinikum RosenheimVerified postcodeRosenheim, Germany· Recruiting
Common questions
What is Herpes Simplex Virus (HSV)?
HSV is a common virus that most people carry. It usually causes cold sores, but in very sick people, it can become active in other parts of the body, like the lungs.
What is acyclovir?
Acyclovir is a medicine used to treat infections caused by herpes viruses. It's an antiviral drug.
Why don't doctors already know if acyclovir helps?
Previous studies hinted it might help, but they weren't designed to give a clear 'yes' or 'no' answer. This study aims to provide that clear answer.
What does 'randomly assigned' mean?
It means patients are put into a treatment group by chance, like drawing names from a hat. This helps make the study fair and reliable.
What is 'pneumonia'?
Pneumonia is a serious infection of the lungs that can make it very difficult to breathe.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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