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Staphylococcus Aureus Infection clinical trials

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NCT ID: NCT06368856 Recruiting - Healthy Clinical Trials

Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study

MUPIPHARM
Start date: February 29, 2024
Phase: Phase 1
Study type: Interventional

Mupirocin is an old antibiotic used topically since the 1970s. Initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for Staphylococcus aureus (SA) carriage, in association with chlorhexidine. This decolonization strategy has been recommended in France for preoperative cardiac surgery in nasal SA carriers since 2013 by the French Hospital Hygiene Society, and recommended for cardiac and orthopedic surgery in SA carriers by the World Health Organization (WHO) since 2016. This strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively. As a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for Staphylococcus aureus carriage), thus further increasing the use of this molecule. Mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of "a match head", i.e. 50 mg, to 500 mg per nostril. Mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. This lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application. It therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy.

NCT ID: NCT06319235 Recruiting - Clinical trials for Surgical Site Infection

Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®

Start date: October 27, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

DUOFAG® is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa. It is an investigational medicinal product for the treatment of surgical site infections caused by S. aureus and P. aeruginosa. The primary objective of the study is to demonstrate the safety of DUOFAG® and the clinical and microbiological change within 10 weeks after the start of treatment or until healing.

NCT ID: NCT06317688 Enrolling by invitation - Breast Feeding Clinical Trials

Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis

Start date: November 6, 2023
Phase: Phase 1
Study type: Interventional

Problem of the Study This study was designed to test the effectiveness of the application of extra-virgin coconut oil versus Highly Purified Anhydrous (HPA) Lanolin in ameliorating nipple pain, cracking and eventually the prevention of subacute lactation mastitis in breastfeeding women. It is theorized that the nipple crack, nipple pain are early warning signs of subacute clinical lactation mastitis. Goal is after application of extra-virgin coconut oil comparative analysis will be done at one week, three weeks, and six weeks. These complications associated with development of subacute mastitis can be addressed early during the first six weeks of lactation.

NCT ID: NCT06210594 Not yet recruiting - Clinical trials for Staphylococcus Aureus Infection

Staph Intervention for Effective Local Defense

SHIELD
Start date: April 2024
Phase: Phase 4
Study type: Interventional

Indigenous persons experience a high burden of Staphylococcus aureus (SA) invasive disease and skin and soft tissue infections. SA carriage on the skin is factor for development of SA infections. The goal of this clinical trial is to evaluate a community-informed approach to reduce carriage of SA. Participants will be assigned to education and household supplies for prevention of SA with and without a biomedical intervention. Researchers will compare SA carriage in the two groups.

NCT ID: NCT05899140 Not yet recruiting - Clinical trials for Staphylococcal Infections

Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial

SoTiClin
Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

This is an exploratory study to evaluate the effect of adjunctive clindamycin in the treatment of skin and soft-tissue infections due to Staphylococcus aureus in patients from Sierra Leone. The study hypothesizes that clindamycin, when added to routine treatment, will lead to a more rapid clinical resolution and less frequent recurrences of infection.

NCT ID: NCT05361135 Not yet recruiting - Sepsis Clinical Trials

18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia

PET-SAB
Start date: September 2023
Phase: N/A
Study type: Interventional

Having bacteria in the blood can be very dangerous. This is called bacteraemia (or bacteremia) or bloodstream infection. It can lead to problems across the whole body, which is what happens in sepsis. Bacteria called Staphylococcus aureus (S. aureus) cause one kind of bacteraemia. Up to a third of people with this condition die within three months, even with antibiotics. One reason for such severe problems is that the bacteria can spread almost anywhere in the body, and hide in places where they are very hard to find. When people with S. aureus bacteraemia come into hospital and have had antibiotics, doctors sometimes cannot tell if they still have an infection source (called a 'focus') hiding in their body. The focus can be like an abscess and may need removing or the pus draining out. A focus might be obvious, if there is pain or swelling, or it might be hidden and deep. If these 'foci' can be found, then doctors can treat them and this helps to cure patients. To improve survival for patients with these life-threatening infections, it is vital that doctors find the focus of S. aureus bacteraemia as quickly as possible. However, the research team do not know the best way to do this. Most patients with S. aureus bacteraemia have a chest X-ray and a scan of the heart valves. Patients may go to the scanning department lots of times while doctors try to work out where these foci are. This is uncomfortable and takes a lot of time. In about 1 in 5 cases the doctors still cannot find the focus. This is very worrying for patients, their relatives and doctors. This study has been designed by researchers, doctors and patient advocates. It aims to work out if fewer patients may die when a specific type of scan called a 'PET/CT' is done quickly, because it finds more foci. To do this the team plan to do a clinical trial in patients with S. aureus bacteraemia. Half of the patients will receive the usual tests that patients currently get and the other half will receive an extra scan as soon as possible. The patients will be chosen randomly (like the flip of a coin) to go into one of the 2 groups. A year into the trial, an independent committee will check the results to make sure the extra scan is finding more foci. If this is the case, the trial will carry on. At the end of the study, we will share the results globally. The findings are expected to change the way this dangerous condition is managed, so patients do better.

NCT ID: NCT05117398 Recruiting - Clinical trials for Staphylococcus Aureus Infection

Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

DALICATH
Start date: June 23, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit). As the secondary objectives, the study aims to evaluate according to treatment group: 1. Cure rate at DAY 14 and DAY 90 (EOS); 2. Mortality rate within 90 days of follow-up; 3. Time to negativation of blood cultures; 4. Patient's quality of life; 5. Hospitalization length of stay; 6. Cost-utility analyses; 7. Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).

NCT ID: NCT04897971 Enrolling by invitation - Clinical trials for Surgical Site Infection

Serum Based Diagnosis of and Monitoring of Infection Recovery in Orthopedic Spine Implant Infections

Start date: August 24, 2021
Phase:
Study type: Observational

The goal of this study is to test a new way to diagnose and track treatment of spine infections caused by the bacteria Staphylococcus aureus.

NCT ID: NCT04803708 Completed - Diabetic Foot Ulcer Clinical Trials

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

REVERSE
Start date: March 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers.

NCT ID: NCT04784312 Completed - Clinical trials for Staphylococcus Aureus Infection

A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection

Start date: April 16, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, first time in human study enrolling approximately 42 healthy adult subjects (18-45 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MW14 in healthy adult volunteers administered as a single IV dose compared with placebo, across 5 cohorts. The 5 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 85 days post dose.