AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

A prospective, randomized, double-blind, placebo-controlled Phase I/IIa Clinical Trial to demonstrate the safety and efficacy of DUOFAG® in bacterial infection treatment in patients with surgical wounds

This research study is looking into a new treatment called DUOFAG for people with infected surgical wounds. They want to check if DUOFAG is safe to use and if it effectively helps wounds heal after surgery, particularly when the infection is caused by bacteria such as S. aureus or P. aeruginosa. The study involves comparing DUOFAG with a standard salt water solution (placebo) to understand its effects better. Researchers will monitor for any side effects and track how quickly wounds start to get better and whether the infection clears up. This is an early-stage study, meaning it's one of the first times DUOFAG is being tested in humans.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

MB PHARMA s.r.o.

Enrolment target

Start

05 Dec 2024

Surgical wound infection/dehiscence caused by S. aureus and/or P. aeruginosa colonization

What is this study about?

Imagine you've had surgery, and your wound has become infected. This can slow down healing and cause discomfort. This study is exploring a new treatment called DUOFAG. The main goal is to find out if DUOFAG can help fight these infections and encourage your wound to heal properly and safely.

Researchers are particularly interested in infections caused by two common types of bacteria, S. aureus and P. aeruginosa. You might hear these referred to as 'superbugs,' but it just means they can be tricky to treat. In this study, some people will receive DUOFAG, while others will get a plain salt water solution (like a dummy treatment, called a placebo). This helps scientists really see if DUOFAG is making a difference, rather than the wound just healing on its own.

The study is in its early stages (called 'Phase I and II'). This means it's among the first times DUOFAG is being given to people. The team will be carefully watching for any side effects and closely tracking how your wound heals and if the infection clears. They will look at things like how quickly the wound starts forming new, healthy tissue and whether the bacteria causing the infection are gone.

Key takeaways

This study is testing a new treatment, DUOFAG, for surgical wound infections.
It's looking at specific bacterial infections: S. aureus and P. aeruginosa.
The study aims to see if DUOFAG is safe and helps speed up wound healing.
Participants will receive either DUOFAG or a placebo (salt water solution).
It's an early-stage study, so safety is a key focus.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can potentially take part.

This study is open to both men and women. The key requirement is that you have a surgical wound that has become infected with specific types of bacteria: S. aureus, P. aeruginosa, or both.

Before you can join, your medical team will do careful checks to make sure the study is a good fit for you and that taking part would be safe.

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?
Do you have a surgical wound that is infected?
Has your doctor told you that your wound infection is caused by S. aureus or P. aeruginosa?
Are you able to attend regular follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new treatment, DUOFAG, or a standard salt water solution, given as an infusion (like a drip). The study team will not know whether you are receiving DUOFAG or the salt water solution, and neither will you.

Throughout the study, you'll have several visits where doctors and nurses will closely monitor your wound. They will check for any reactions, take swabs from your wound to see if the infection is clearing, and measure how quickly the wound is healing. They will also ask about your general well-being and any symptoms you might be experiencing. The total duration of your participation and the number of visits would be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer the benefit of potentially receiving a new treatment that could help your infected surgical wound heal. However, like all new treatments, there's always a possibility of unknown side effects. You might experience common side effects like skin reactions, fever, or stomach upset, or more serious ones. You will be closely monitored for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your future 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
Czechia

Common questions

What kind of infection is this study looking at?

This study is focusing on infections in surgical wounds caused by specific bacteria called S. aureus and/or P. aeruginosa.

What is DUOFAG?

DUOFAG is the new treatment being tested in this study to see if it's safe and effective for treating certain surgical wound infections.

Will I know if I'm getting DUOFAG or the salt water solution?

No, neither you nor the study team will know which treatment you are receiving. This is to ensure fair results.

What does 'Phase I/II' mean?

This means it's an early-stage study, among the first times the treatment is being given to people, to check for safety and early signs of how well it works.

What will researchers be checking for?

They will be checking for side effects, how quickly your wound starts healing, and if the bacterial infection clears up.