Ongoing Clinical Trials for Staphylococcal Infections
There are currently 6 ongoing clinical trials exploring new treatment approaches for staphylococcal infections, including MRSA (methicillin-resistant Staphylococcus aureus). These trials are testing various treatments including nasal decolonization gels, inhaled antibiotics, continuous antibiotic infusions, bacteriophage therapy, oral antibiotic combinations, and new intravenous antibiotic regimens. The trials are being conducted across multiple European countries, with the goal of finding safer and more effective ways to eliminate these resistant bacterial infections.
Clinical trial locations
- Denmark
- France
- Study on Dalbavancin and Rifampicin for Treating Prosthetic Joint Infections in Patients with Hip, Knee, and Shoulder Replacements
- Study on the Effectiveness of Povidone-Iodine for Nasal Decolonization in Patients with MRSA
- Study of PP1493 and PP1815 phage therapy for patients with knee or hip joint infections caused by Staphylococcus aureus after prosthetic surgery
- Italy
- Netherlands
- Spain
- Sweden
Study on the Effectiveness of Povidone-Iodine for Nasal Decolonization in Patients with MRSA
This trial focuses on eliminating MRSA from the nose using a nasal gel containing povidone-iodine, a substance known for killing bacteria. The study aims to evaluate how effectively this treatment can clear MRSA from nasal passages.
Who can participate: Adults over 18 years old who have been in the hospital for more than 4 days and have tested positive for MRSA through nasal screening. Participants must be part of the French social security system and provide written informed consent.
Who cannot participate: Patients who do not have MRSA or those outside the specified age range cannot take part in this study.
What the study involves: Participants will use a povidone-iodine nasal gel as part of a complete decolonization kit. The study will measure how well the gel clears MRSA from the nose six hours after application, and again after 24 hours. Researchers will also assess how acceptable the treatment is to patients and healthcare workers through questionnaires, and monitor any side effects.
Treatment being tested: The investigational product is a povidone-iodine gel applied inside the nose. This antiseptic works by releasing iodine, which kills bacteria by disrupting their essential components.
Study on the Safety of Inhaled Teicoplanin for Treating Staphylococcus aureus Infections in Cystic Fibrosis Patients
This trial evaluates the safety and tolerability of teicoplanin, an antibiotic delivered through inhalation, for patients with cystic fibrosis who have persistent Staphylococcus aureus infections, including MRSA.
Who can participate: Males and females aged 12 years or older with confirmed cystic fibrosis and persistent Staphylococcus aureus infection, demonstrated by at least three positive sputum tests within the last 24 months. Participants must have lung function between 50% and 90% of predicted values and be able to understand and follow study requirements.
Who cannot participate: Those without cystic fibrosis with persistent Staphylococcus aureus infection, people outside the specified age range, pregnant or breastfeeding women, and those taking medications that might interfere with the study drug.
What the study involves: Participants will inhale teicoplanin at a dose of 200 mg twice daily in two 28-day treatment cycles, separated by a 28-day break. Throughout the study, lung function tests, bacterial load measurements, and symptom assessments will be conducted to monitor safety and effectiveness.
Treatment being tested: Teicoplanin is a glycopeptide antibiotic that works by inhibiting bacterial cell wall synthesis. It is delivered directly to the lungs through inhalation.
Study of Continuous Infusion of Cloxacillin Using Elastomeric Pump in Adult Patients with Staphylococcus Aureus Infection
This study evaluates whether continuous delivery of the antibiotic cloxacillin using a portable elastomeric pump maintains proper medication levels in the blood to fight infection effectively.
Who can participate: Adults aged 18 years or older whose doctor determines they are suitable to switch from regular intermittent antibiotic doses to continuous cloxacillin infusion. Participants must be receiving a daily dose of 6-12 grams of cloxacillin and be able to provide informed consent.
Who cannot participate: People outside the age range, those with known allergies to cloxacillin or similar antibiotics, patients with severe kidney or liver problems, pregnant or breastfeeding women, those with blood infections caused by bacteria other than Staphylococcus aureus, and people currently participating in other trials.
What the study involves: Participants will receive cloxacillin continuously through an elastomeric pump for up to 6 weeks. Blood samples will be taken at the start of treatment and at 4, 24, and 48 hours to measure medication levels in the blood.
Treatment being tested: Cloxacillin is a penicillin-class antibiotic that interferes with bacterial cell wall synthesis. The elastomeric pump is a small, portable device that delivers medication continuously through a thin tube connected to the patient’s vein.
Study of PP1493 and PP1815 phage therapy for patients with knee or hip joint infections caused by Staphylococcus aureus after prosthetic surgery
This innovative trial tests bacteriophage therapy, which uses specific viruses to target and destroy bacteria, as an addition to standard surgical treatment for prosthetic joint infections.
Who can participate: Adults at least 18 years old with hip or knee joint infections caused by Staphylococcus aureus bacteria, with a life expectancy of more than one year. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control. Participants must have a single bacterial infection and be eligible for the DAIR surgical procedure.
Who cannot participate: Those under 18 years, patients with infections not caused by Staphylococcus aureus, infections in joints other than hip or knee, pregnant or breastfeeding women, those with known allergies to study medications, patients with severe immune system disorders, and those who received antibiotics within 48 hours before study start.
What the study involves: Participants will be randomly assigned to receive either bacteriophage therapy or placebo, both given by injection directly into the joint during the DAIR cleaning procedure. All participants will also receive standard antibiotics. Follow-up continues for 12 months with regular check-ups, blood tests, joint fluid samples, and X-rays.
Treatment being tested: PP1493 and PP1815 are bacteriophage solutions that specifically attack Staphylococcus aureus bacteria. These viruses target and destroy harmful bacteria while leaving human cells unaffected, combined with the DAIR surgical procedure.
Study comparing standard decolonization therapy alone versus combined with oral clindamycin for patients with MRSA throat carriage
This trial investigates whether adding the oral antibiotic clindamycin to standard treatment improves elimination of MRSA from the throat.
Who can participate: Adults aged 18 years or older who have MRSA bacteria in their throat and have already completed one course of standard topical decolonization treatment. Participants must be able to take part in a randomized clinical trial.
Who cannot participate: Those with known allergies to clindamycin, mupirocin, or chlorhexidine; pregnant or breastfeeding women; patients with active gastrointestinal infections or severe digestive problems; those who used antibiotics in the past 2 weeks; patients with severe liver or kidney disease; people with inflammatory bowel disease or immunocompromised status; those under 18 years; and people unable to give informed consent.
What the study involves: Participants receive standard decolonization therapy (mupirocin nasal ointment and chlorhexidine body wash) plus either oral clindamycin or placebo for 10 days. Throat swabs are taken after one month and six months to check if MRSA bacteria are still present.
Treatment being tested: The study tests clindamycin, a lincosamide antibiotic that prevents bacteria from producing essential proteins, in combination with mupirocin (a topical antibiotic for nasal application) and chlorhexidine (an antiseptic body wash).
Study on Dalbavancin and Rifampicin for Treating Prosthetic Joint Infections in Patients with Hip, Knee, and Shoulder Replacements
This trial evaluates the combination of dalbavancin and rifampicin for treating infections that occur in artificial joints after replacement surgery.
Who can participate: Adults 18 years or older with prosthetic joint infections in the knee, hip, or shoulder caused by staphylococcus bacteria sensitive to both dalbavancin and rifampicin. The infection must have been treated surgically through DAIR or one-stage or two-stage joint replacement. Participants must have social security affiliation.
Who cannot participate: Patients outside the specified age range and those who are part of vulnerable populations.
What the study involves: Participants receive dalbavancin as an intravenous infusion combined with oral rifampicin. Regular follow-up appointments monitor treatment effectiveness and any side effects over 12 months after surgery, with extended observation potentially continuing to 24 months.
Treatment being tested: Dalbavancin is a lipoglycopeptide antibiotic given intravenously that interferes with bacterial cell wall building. Rifampicin is an oral antibiotic used to combat staphylococcal infections. The combination aims to improve treatment outcomes for prosthetic joint infections.
Summary
The six ongoing clinical trials for staphylococcal infections demonstrate diverse approaches to combating these resistant bacteria. France leads with three trials, focusing on nasal decolonization, bacteriophage therapy for prosthetic joint infections, and combination antibiotic treatment. The remaining trials are distributed across Denmark, Italy, Sweden, Spain, and the Netherlands.
Several trials specifically target MRSA, the antibiotic-resistant form of Staphylococcus aureus, testing novel approaches such as povidone-iodine nasal gel and bacteriophage therapy. Prosthetic joint infections are a particular focus, with two trials exploring different treatment strategies for these challenging infections. One trial uniquely addresses cystic fibrosis patients with persistent infections through inhaled antibiotics.
The trials employ various administration methods including topical gels, inhalation, continuous infusion through portable pumps, oral medications, and intravenous infusions. Some studies test innovative treatments like bacteriophage therapy, which uses viruses to specifically target harmful bacteria, representing a potentially groundbreaking approach to antibiotic-resistant infections.
Most trials include standard safety monitoring and follow-up periods ranging from several months to two years, ensuring comprehensive evaluation of both short-term and long-term treatment outcomes.
