Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

COTRIVAP - Efficacy of cotrimoxazole as a de-escalation treatment of Ventilator-Associated Pneumonia in intensive care unit. Multicentric non-inferiority randomised controlled trial

This important study, called COTRIVAP, investigates new ways to treat pneumonia in people who are on a breathing machine in intensive care. Doctors want to see if an antibiotic called co-trimoxazole works as well as the usual treatments. This could mean fewer side effects, less antibiotic resistance, or a different treatment option for patients. The study will carefully compare these treatments to make sure they are safe and effective. It's a large-scale study involving many hospitals, aiming to find the best care for these very sick patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

628

Start

20 Jul 2023

Intensive Care Ventilator-associated Pneumonia

What is this study about?

Imagine you're in intensive care and need help breathing from a machine (a ventilator). Sometimes, people in this situation can get a lung infection called ventilator-associated pneumonia (VAP). This study, called COTRIVAP, is all about finding the best way to treat this infection.

Current treatments use various strong antibiotics. This study is looking at whether a different, older antibiotic called co-trimoxazole works just as well as these current treatments. This is important because using a different antibiotic might help reduce side effects, or help stop germs from becoming resistant to antibiotics over time.

Researchers will carefully monitor important things like whether people recover, how long they need a breathing machine, and how long they stay in hospital. They will also check for any side effects and see if the new treatment changes how bacteria behave. The aim is to make sure any new approach is just as effective and safe as what doctors currently use.

Key takeaways

Researchers are looking for a new or better way to treat pneumonia in critically ill patients.
The study compares a common antibiotic (co-trimoxazole) to current standard treatments.
The aim is to see if co-trimoxazole is just as effective and safe.
This could lead to more treatment options for patients on breathing machines.
Participation involves close monitoring of health and recovery.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or over. There's no upper age limit, so people of all adult ages can be considered.

You would need to be a patient in an intensive care unit and have developed pneumonia while on a breathing machine (a ventilator).

Both men and women can be part of this study.

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 currently in intensive care?
Do you have pneumonia that developed while on a breathing machine?
Are you comfortable with the idea of possibly receiving a different antibiotic?
Are you willing to have your health closely monitored for up to 90 days?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the standard antibiotic treatment for your pneumonia or the study antibiotic, co-trimoxazole. The medical team would decide which one you receive, similar to a coin flip, to make the comparison fair. They would then closely monitor your health and recovery over the next 28 days, and also check on your vital status after 90 days.

Throughout the study, the medical team will carry out regular checks, including looking at your general health, taking blood tests, and possibly reviewing x-rays to see how the pneumonia is improving. They will also keep track of how many days you need the breathing machine and how long you stay in the intensive care unit and hospital. The main focus is on how well you recover from the pneumonia, including any side effects from the medication. You would continue to receive care until you are discharged from the intensive care unit.

Potential risks and benefits

Participating in this study might offer the benefit of receiving an alternative treatment for your pneumonia that could be just as effective as standard care. Researchers hope to find treatments that are not only effective but also have fewer side effects or help tackle antibiotic resistance. As with any medication, there's always a chance of side effects or allergic reactions, which the medical team will monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting the quality of your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'ventilator-associated pneumonia'?

It's a type of lung infection that can affect patients who are on a breathing machine (ventilator) in intensive care.

What is co-trimoxazole?

It's an antibiotic, a type of medicine used to treat infections caused by bacteria.

Will I know which treatment I'm getting?

Usually, in studies like this, you won't know if you're getting the study drug or the standard treatment, to keep the comparison fair and unbiased.

What is a 'Phase III' study?

This means the treatment has already shown promise in earlier stages and is now being tested on a larger group of patients to confirm its effectiveness and safety compared to existing treatments.

What does a 'vital status at day 28' mean?

This is a key way the researchers measure how well patients are doing, by checking on their health status 28 days after starting treatment.