Study on the Effectiveness of Autovaccines Compared to Antibiotics for Patients with Hip or Knee Prosthesis Infections

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What is this study about?

This clinical trial is focused on evaluating treatments for infections in patients with hip or knee prostheses. These infections can be challenging to treat, especially when a cure is not possible. The study aims to compare the effectiveness of two different treatments: one using autovaccines and the other using antibiotics. Autovaccines are a type of vaccine made from bacteria taken from the patient’s own body, and in this study, they are administered through the sublingual mucosa, which means they are given under the tongue.

The antibiotics being studied include fluconazole, sulfamethoxazole and trimethoprim, amoxicillin, metronidazole, ciprofloxacin, amoxicillin and beta-lactamase inhibitor, clindamycin, doxycycline, and linezolid. These medications are commonly used to treat bacterial infections and will be compared to the autovaccine treatment to see which is more effective in reducing symptoms like pain, redness, and wound exudate, which is a fluid that can leak from infected areas.

The purpose of the study is to determine if autovaccines can help decrease the symptoms and progression of infections in patients with joint prostheses. Participants will receive either the autovaccine or antibiotic treatment over a period of up to 12 weeks. The study will monitor the clinical course of the infection and assess the safety of the treatments by observing any local or systemic adverse events, which are unwanted effects that can occur in the body. The trial is expected to provide valuable insights into the management of prosthetic joint infections.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes verifying that the patient is over 18 years old, has a hip or knee prosthesis with an active infection, and has signed the informed consent form.

2 treatment allocation

Patients are allocated to one of two treatment groups: those receiving autovaccines or those receiving antibiotic treatment.

3 autovaccine administration

For patients in the autovaccine group, the treatment is administered through the sublingual mucosa. This involves placing the vaccine under the tongue, allowing it to be absorbed directly into the bloodstream.

4 antibiotic treatment

Patients in the antibiotic group receive one of the following medications orally: fluconazole, sulfamethoxazole and trimethoprim, amoxicillin, metronidazole, ciprofloxacin, amoxicillin and beta-lactamase inhibitor, clindamycin, doxycycline, or linezolid. The specific medication, dosage, and frequency are determined by the study protocol.

5 monitoring and follow-up

Throughout the trial, patients are monitored for clinical symptoms such as exudate, redness, and pain. Safety assessments are conducted to identify any local or systemic adverse events.

6 trial completion

The trial is expected to conclude by February 16, 2026. At the end of the trial, the effectiveness of the treatments in reducing symptoms and infection progression will be evaluated.

Who Can Join the Study?

Patients must be over 18 years of age.
Patients must have a hip or knee prosthesis and be diagnosed with an active infection.
Patients must not have the possibility of a curative treatment, meaning a treatment that can completely cure the infection.
Patients must be willing to sign the informed consent form, which is a document that explains the study and confirms their agreement to participate.
Patients must have monomicrobial infections, which means the infection is caused by only one type of bacteria.

Who Cannot Join the Study?

Patients with hip or knee infections cannot participate. This means if you have an infection in your hip or knee, you are not eligible for the study.

Where you can join this trial?

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Site Name	City	Country	Status
Htcalkzg Uvjvmoqyncuhl Mlypisj Do Vmxgjwkcoz	Santander	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	16.02.2024

Trial locations

Investigated drugs:

Autovaccines are personalized vaccines made from bacteria taken from the patient’s own infection. In this trial, they are used to help the body fight the infection by stimulating the immune system. The autovaccines are administered through the sublingual mucosa, which means they are placed under the tongue to be absorbed.

Suppressive Antibiotic Treatment involves using antibiotics to control the infection and prevent it from getting worse. This treatment does not aim to cure the infection completely but to manage the symptoms and slow down the progression of the infection in patients with hip or knee prosthesis infections.

Joint Prosthesis Infection – This condition occurs when bacteria or other microorganisms infect the area around a joint replacement, such as a hip or knee. It can lead to symptoms like pain, swelling, redness, and warmth around the joint. The infection may cause the joint to become stiff and difficult to move. Over time, the infection can damage the surrounding tissues and the prosthesis itself. If not managed, it may lead to the loosening of the joint implant. The progression of symptoms can vary depending on the severity and type of infection.

Trial ID:

2024-520226-10-00

Protocol code:

VACAB-2022

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Autovaccines Compared to Antibiotics for Patients with Hip or Knee Prosthesis Infections

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?