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Testing Bacteriophage Cocktail Safety and Effectiveness in Patients with Complicated Infected Wounds Compared to Placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines the treatment of complicated skin wounds that are infected with certain bacteria. The wounds being studied include infected surgical wounds, traumatic wounds, or chronic wounds that are healing slowly and are infected with either Staphylococcus aureus or Pseudomonas aeruginosa bacteria, or both. The study will test a treatment called DUOFAG, which is a bacteriophage cocktail applied directly to the wound. Bacteriophages are viruses that specifically target and destroy bacteria. The treatment will be compared to a placebo, which is sodium chloride solution.

The purpose of this study is to show whether DUOFAG is safe and can reduce or completely eliminate Staphylococcus aureus and Pseudomonas aeruginosa bacteria from infected wounds over a period of 14 days. The study will also look at how often any unwanted reactions occur during treatment and whether the treatment helps wounds heal better.

During the study, the treatment will be applied directly to the wound for up to 14 days. Samples from the wound will be taken regularly to check whether the bacteria are still present and to count how many bacteria remain. The study will monitor participants for any side effects during the treatment period and for some time afterward. The study will also measure changes in the wound condition and track how long it takes for the infection to clear and for the wound to heal completely if this happens during the study period.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment application</b>

    A cutaneous solution (a liquid applied to the skin) is applied directly to the complicated skin wound.

    The treatment consists of either the test product, duofag, or a placebo (a substance without active medicine, in this case, sodium chloride solution).

    The duofag solution contains a specific concentration of 50,000,000,000 pfu (plaque forming units, a measure of the amount of virus in the solution).

    The application is performed topically on the wound for a duration of 14 days.

  2. Step 2

    <b>monitoring and evaluation</b>

    During the 14-day application period, the presence of bacteria, specifically staphylococcus aureus and pseudomonas aeruginosa, is monitored.

    The effectiveness is evaluated using wound swabs (using a small piece of absorbent material to collect samples from the wound) and stamp examinations.

    The goal is to observe the reduction or the complete eradication (total removal) of these bacteria.

    Any adverse reactions (unwanted side effects) occurring locally at the wound site or throughout the body are recorded to evaluate safety.

Who can join the trial?

7 criteria

  • You have a wound infection, which means you have an open wound that has become infected with bacteria. This can be a surgical wound (from an operation), a traumatic wound (from an injury), or a chronic wound (a wound that has not healed for a long time).
  • Your wound is infected with specific bacteria called S. aureus or P. aeruginosa, which will be confirmed by taking a sample from your wound using a swab (a cotton-like stick used to collect bacteria from the wound surface).
  • The bacteria found in your wound must be able to be treated by the study medication, which will be tested in a laboratory.
  • You are between 18 and 80 years old.
  • You do not have any medical reasons that would make it unsafe for you to use the planned medication.
  • You are willing to sign a consent form after understanding the study and agree to follow all the study requirements.
  • If you are a man or woman who cannot have children (either because of menopause, which is when a woman stops having monthly periods naturally, or because your uterus and/or ovaries have been removed through surgery), you can participate. If you are a woman who can still have children, you must have a negative pregnancy test at the first visit and agree to use a reliable method of contraception (birth control) during the study.

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the provided information.
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Investigated drugs

DUOFAG is an investigational medication being tested for treating bacterial infections in patients with complicated wounds. It is designed to reduce or completely eliminate certain bacteria, specifically Staphylococcus aureus and Pseudomonas aeruginosa, which are common bacteria that can infect wounds and prevent them from healing properly. The medication is applied directly to the wound over a period of two weeks to help fight the infection and improve wound healing.

What is already known about the treatment

DUOFAG – DUOFAG is an investigational medication currently being studied in phase IIb clinical trials for treating bacterial infections in complicated skin wounds that heal through granulation tissue, including infected surgical wounds, traumatic wounds, and chronic wounds. The medication is specifically designed to target and eliminate two common bacteria found in infected wounds: Staphylococcus aureus (S. aureus) and Pseudomonas aeruginosa (P. aeruginosa). It is applied directly to the wound site, and the treatment aims to reduce or completely eliminate these harmful bacteria over a 14-day period, helping infected wounds to heal properly.

Investigated diseases

  • Staphylococcal Wound Infection

    This is a bacterial infection of wounds caused by Staphylococcus aureus bacteria. The infection can occur in surgical wounds, traumatic wounds, or chronic wounds that are not healing properly. When present, the bacteria multiply in the wound tissue and prevent normal healing processes. The wound may show signs of infection such as redness, swelling, warmth, and discharge. Instead of healing directly, the wound must heal through a slower process involving the formation of granulation tissue. This type of infection complicates the wound healing process and requires the wound to close from the bottom up rather than the edges coming together.

  • Pseudomonas Wound Infection

    This is a bacterial infection of wounds caused by Pseudomonas aeruginosa bacteria. This organism commonly infects wounds that are already damaged or not healing well. The bacteria can colonize both acute wounds such as those from surgery or injury, and chronic wounds that have been present for extended periods. Pseudomonas infection interferes with the normal wound healing process and causes the wound to heal through secondary intention with granulation tissue formation. The presence of this bacteria in wounds often leads to delayed healing and complications. Like other wound infections, it prevents the wound edges from closing directly and requires a longer healing time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-522752-45-00Protocol codeDUO2025_01Estimated enrolment100 patientsSponsorMB PHARMA s.r.o.

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