[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"staphylococcus-aureus-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:staphylococcus-aureus-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,78,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100614515","phase-1-safety-of-combined-intravenous-antibiotic-and-bacteriophage-therapy-in-adults-with-cystic-fibrosis-and-antibiotic-resistant-lung-infections-100614515",false,"NCT07280598","Safety of Combined Intravenous Antibiotic and Bacteriophage Therapy in Adults With Cystic Fibrosis and Antibiotic-Resistant Lung Infections","Taking Advantage of Phage Technologies (TAPT) to Facilitate Phage Therapy While Reducing the Use of Antibiotics in the Management of Cystic Fibrosis (CF)","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed diagnosis of cystic fibrosis.\n* Sputum culture within 24 months and at screening showing at least one of the following: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans.\n* Percent predicted FEV₁ ≥ 40% (GLI).\n* If ppFEV₁ \\> 40%, must have ≥ 1 pulmonary exacerbation per year requiring IV antibiotics or radiographic evidence of severe disease.\n* Prior successful home IV antibiotic therapy within 5 years (may be waived by investigator).\n* Available phage cocktail with lytic activity against the participant's pathogen.\n\nOxygen saturation \\> 88% on room air after rest. Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Untreated or uncontrolled mycobacterial or fungal airway infection.\n* History of Clostridioides difficile without a negative test within 3 months. Concerning exotoxin, virulence, or resistance genes in the bacterial isolate (per investigator).\n* Mixed-species bacterial infection at screening.\n* Participation in another interventional trial within 30 days.\n* Allergy or hypersensitivity to study materials.\n* Pregnancy, planned pregnancy, or breastfeeding.\n* Any condition or abnormality that, in the investigator's judgment, makes participation unsafe or may interfere with study assessments.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1, open-label, multi-center pilot study evaluating the safety and microbiological activity of intravenous (IV) bacteriophage therapy in combination with standard IV antibiotics in adults with cystic fibrosis (CF) experiencing pulmonary exacerbations due to antibiotic-resistant bacterial infections. Eligible participants will receive a 7-day course of IV antibiotics, selected by their treating clinician, along with a phage cocktail specifically formulated to target their identified bacterial pathogen (Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans). The primary objective is to assess the safety and tolerability of this combined treatment approach. Secondary and exploratory outcomes include assessment of changes in sputum bacterial burden, lung function (spirometry and oscillometry), quality of life, and bacteriophage pharmacokinetics. Results from this study will inform the feasibility and design of future clinical trials using phage therapy in the CF population.",[26,27,28,29,30,31],"CF - Cystic Fibrosis","Klebsiella Pneumoniae Infection","E Coli Infections","Staphylococcus Aureus Infection","Achromobacter","Stenotrophomonas Maltophilia Infection",[33,34,35,36],"cystic fibrosis","CF","Phage","bacteriophage","NOT_YET_RECRUITING","2025-12-09",{"date":40,"type":41},"2025-12-12","ACTUAL",{"date":43,"type":20},"2025-12-31",{"date":45,"type":20},"2027-01-30",{"name":47,"class":48},"University of California, San Diego","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100448280","phase-3-dalbavancin-versus-standard-antibiotic-therapy-for-catheter-related-bloodstream-infections-due-to-staphylococcus-aureus-100448280","NCT05117398","Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus","Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus","DALICATH","Inclusion Criteria:\n\n* Patients aged at least 18 years;\n* Blood cultures positive for S. aureus, obtained within 72 hours before randomization (the date considered is the date of the sampling, not the results);\n* CR-BSI, defined as:\n\n  * One positive blood culture AND Local signs of infection at the catheter site; OR\n  * at least one positive blood culture obtained from the catheter and the peripheral vein; AND\n  * A differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended; AND\n  * Same S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures; OR\n  * One positive blood culture; AND\n  * Strong presumption of catheter-related infection according to clinical opinion.\n* Intravascular catheter - implantable venous access device (port-a-cath and Piccline) - removed before randomization;\n* Informed consent form date and signed by the patient.\n\nExclusion Criteria:\n\n* Polymicrobial infection;\n* Dalbavancin resistant strain;\n* More than 72 hours of active antibiotic treatment targeting S. aureus (in-vitro susceptibility) administered prior to randomization;\n* Patient with known valvulopathy, previous history of endocarditis, or suspicion of infective endocarditis by physician in charge;\n* Suspicion of any other deep focus infections, such as arthritis, pneumonia, osteomyelitis, or meningitis, presence of cerebral or peripheral emboli (arterial occlusion);\n* Thrombophlebitis;\n* Failure to remove any intravascular catheter which was present when first positive blood culture;\n* Signs of infection associated with quick SOFA score ≥ 2 at randomization;\n* Patients with foreign bodies such as: prosthetic heart valve, endovascular prosthesis, ventriculo-atrial shunt, pacemaker, or an automated implantable cardioverter defibrillator (AICD) device;\n* Severe liver disease (Child-Pugh C);\n* Severely immunocompromised patients:\n\n  * Neutropenia (\\\u003C 500 neutrophils\u002FµL) at randomization;\n  * Hematopoietic stem cell transplantation within the past 6 months or planned during treatment period;\n  * Solid organ transplant;\n* Contraindication to dalbavancin and\u002For glycopeptide;\n* Life expectancy \\\u003C 3 months;\n* Active injection drug user;\n* Pregnant or breastfeeding women;\n* For premenopausal women: failure to use highly-effective contraceptive methods for 1 month after receiving study drug;\n* Participation in other interventional trials ongoing;\n* Persons held in an institution by legal or official order;\n* Patients under legal protection;\n* Patients under guardianship or curators;\n* Patients unable to give a free and informed consent;\n* Patient not affiliated to a social security scheme: obligation of affiliation to a social security scheme or to be a beneficiary.",{"count":58,"type":20},406,[60],"PHASE3","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).\n\nAs the secondary objectives, the study aims to evaluate according to treatment group:\n\n1. Cure rate at DAY 14 and DAY 90 (EOS);\n2. Mortality rate within 90 days of follow-up;\n3. Time to negativation of blood cultures;\n4. Patient's quality of life;\n5. Hospitalization length of stay;\n6. Cost-utility analyses;\n7. Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).",[63,29],"Catheter Bacteremia",[65,66],"catheter-related bloodstream infections","Staphylococcus aureus infection","RECRUITING","2025-04-04",{"date":70,"type":41},"2025-04-06",{"date":72,"type":41},"2023-06-23",{"date":74,"type":20},"2026-09-23",{"name":76,"class":48},"Assistance Publique - Hôpitaux de Paris",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100508340","phase-4-adjunctive-clindamycin-for-the-treatment-of-skin-and-soft-tissue-infections-a-randomized-controlled-trial-100508340","NCT05899140","Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial","Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial","SoTiClin","Inclusion Criteria:\n\n1. Adults (age ≥18 years);\n2. Need for a treatment (incision\u002Fdrainage ± antibiotic treatment po or iv) of an SSTI;\n3. S. aureus causing SSTI identified from at least one clinical specimen (including isolation in polymicrobial cultures if S. aureus is considered to be the leading pathogen);\n4. Onset of symptoms within the last 4 weeks;\n5. Randomisation possible within 72 hours from collection of the initial culture\n6. Ability to conduct the follow-up visits either during admission or at home\n7. Initial culture collected within 48 hours of hospital admission\n8. Willingness to participate in the study.\n\nExclusion Criteria\n\n1. Previous allergic reaction to clindamycin\n2. Previous antibiotic-associated diarrhea\n3. Previous study participation\n4. Pregnancy as confirmed by a beta-HCG rapid test.\n5. Started treatment with clindamycin prior to clinic presentation;\n6. Documented systemic antibiotic treatment within the previous 14 days\n7. Co-administration of other protein synthesis inhibitors (e.g. macrolides, rifampicin, linezolid, aminoglycosides, tetracyclines, chloramphenicol);\n8. Co-administration of toxin inducers (trimethoprim-sulfamethoxazole)\n9. Severe illness (patient expected to die in the following 24 hrs);\n10. Chronically infected wounds (\\>4 weeks of symptoms);\n11. Infections associated with any of the following (due to mixed infection): a) Human or animal bites;b) Prosthetic or implantable devices; c) Decubitus ulcers; d) Diabetic foot ulcers, infected ulcers secondary to peripheral artery disease, chronic venous insufficiency; e) Suspected Buruli ulcer; f) Infected burns.\n12. Hospital-acquired infection including post-surgical site infections",{"count":87,"type":20},100,[89],"PHASE4","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.",[92,93,29],"Skin Infection","Staphylococcal Infections",[95,96,97],"SSTI","Staphylococcus aureus","Panton-Valentine leukocidin","2024-12-04",{"date":100,"type":41},"2024-12-09",{"date":102,"type":41},"2024-03-15",{"date":104,"type":20},"2026-07-31",{"name":106,"class":48},"Frieder Schaumburg",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":120,"conditions":121,"keywords":128,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100467006","18-fluorodeoxyglucose-positron-emission-tomographycomputed-tomography-in-s-aureus-bacteraemia-100467006","NCT05361135","18-fluorodeoxyglucose Positron Emission Tomography\u002FComputed Tomography in S. Aureus Bacteraemia","18-fluorodeoxyglucose Positron Emission Tomography\u002FComputed Tomography in Staphylococcus Aureus Bacteraemia (Bacteremia\u002FBloodstream Infection); an International, Multicentre, Randomised Control Trial","PET-SAB","Inclusion Criteria:\n\n* Adult (≥18 years of age)\n* Staphylococcus aureus complex grown from ≥1 blood culture\n* Symptoms of S. aureus bloodstream infection\n* Admitted to a participating hospital at the time of eligibility assessment . Agrees to PET\u002FCT\n\nExclusion Criteria:\n\n* Contraindication to PET\u002FCT (including pregnancy\u002Fbreast-feeding)\n* PET\u002FCT in the last 7 days or already planned to occur in the next 7 days\n* Treating team deems enrolment in the study is not in the best interest of the patient\n* Treating team believes that death is imminent and inevitable\n* Patient is for end-of-life care and PET\u002FCT is considered not appropriate",{"count":117,"type":20},820,[119],"NA","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.\n\nTo 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.\n\nThis 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\u002FCT' 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.",[122,123,124,125,126,29,127],"Staphylococcus Aureus Bacteremia","Staphylococcus Aureus Septicemia","Sepsis Bacterial","Bloodstream Infection","Staph Sepsis","Sepsis",[129,122,123,127,124,126,29,125,130,131,132,133,134,135,136],"Staphylococcus","Staphylococcus Aureus Bacteraemia","PET","PET\u002FCT","PET-CT","Positron Emission Tomography","Positron Emission Tomography\u002FComputed Tomography","Diagnostic Imaging","2023-05-10",{"date":139,"type":41},"2023-05-15",{"date":141,"type":20},"2023-09",{"date":143,"type":20},"2026-07",{"name":145,"class":48},"University College, London"]