[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antibiotic-side-effect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antibiotic-side-effect":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,80,106,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100492978","phase-3-po-vs-iv-antibiotics-for-the-treatment-of-infected-nonunion-of-fractures-after-fixation-100492978",false,"NCT05699174","PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","POvIV2","Inclusion Criteria:\n\n1. 1\\. Bone fracture (proximal to and including the tarsal\u002Fmetatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.\n2. Infection as determined by either\n\n   1. FRI criteria\n   2. CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon\n3. Systemic antibiotic treatment regimen scheduled for at least 6 weeks\n\nExclusion Criteria:\n\n1. Patients with a high risk of amputation based on the initial managing physician\n2. Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment\n3. Incarcerated or institutionalized patients\n4. Patients who are unable to return for required follow-up visits and\u002For medical co-morbidities which preclude treatment with a general anesthetic\n5. Patients with a prior history of chronic infection at the index site before fracture fixation\n6. Patients with pathological fractures from a neoplastic process\n7. History of Paget's Disease\n8. The patient, or a designated proxy, unwilling to provide consent\n9. The patient must be available for follow-up for at least 12 months following infection treatment","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.",[27,28,29,30,31,32,33,34,35],"Infections","Infected Wound","Nonunion of Fracture","Injury Leg","Amputation","Internal Fixation; Complications, Infection or Inflammation","Fracture","Lower Extremity Fracture","Antibiotic Side Effect","RECRUITING","2026-06-09",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":40},"2023-05-30",{"date":44,"type":21},"2028-09-29",{"name":46,"class":47},"Major Extremity Trauma Research Consortium","OTHER",13,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100418616","phase-3-local-antibiotics-for-breast-implants-100418616","NCT04731025","Local Antibiotics for Breast Implants","Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial (The BREAST-AB Trial)","BREAST-AB","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Biologically female\n* Signed informed consent\n* Scheduled for breast reconstruction with implants or expanders including:\n\n  1. Immediate or delayed reconstructions\n  2. Bilateral or unilateral reconstructions\n  3. With or without simultaneous flap reconstruction\n\nExclusion Criteria:\n\n* Pregnancy\n* Breast feeding\n* Known allergy towards Vancomycin, Gentamicin and Cefazolin\n* Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides\n* Known allergy towards neomycin\n* Known impaired renal function with GFR \\\u003C 60 mL\u002Fmin\n* Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity\n* Myasthenia Gravis",true,"FEMALE",{"count":60,"type":21},1003,[24],"The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.",[64,65,66,67,68,69,35],"Implant Complication","Implant Infection","Implant Site Infection","Implant Capsular Contracture","Implant Site Pocket Infection","Implant Expulsion","2026-02-09",{"date":72,"type":40},"2026-02-12",{"date":74,"type":40},"2021-01-27",{"date":76,"type":21},"2027-08",{"name":78,"class":47},"Mikkel Herly",8,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100581469","evaluation-of-bifidobacterium-breve-prl2020-in-preventing-antibiotic-associated-side-effects-from-amoxicillin-or-amoxicillinclavulanic-acid-100581469","NCT06850714","Evaluation of Bifidobacterium Breve PRL2020 in Preventing Antibiotic-Associated Side Effects From Amoxicillin or Amoxicillin\u002FClavulanic Acid","Evaluation of the Use of Bifidobacterium Breve PRL2020 in Preventing Side Effects From Amoxicillin or Amoxicillin\u002FClavulanic Acid Antibiotic Use: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 3 to 12 years\n* Requiring antibiotic therapy with Amoxicillin or Amoxicillin\u002FClavulanic Acid\n* Ability to comply with the study protocol (parents\u002Fcaregivers must complete symptom diaries)\n\nExclusion Criteria:\n\n* Use of any antibiotic therapy within 3 months before study enrollment\n* Known gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease)\n* History of chronic diarrhea or constipation\n* Allergy to probiotics or study interventions\n* Any immunocompromised state","3 Years","12 Years",{"count":90,"type":21},800,[92],"NA","This study aims to evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 in preventing gastrointestinal and extra-intestinal side effects caused by Amoxicillin or Amoxicillin\u002FClavulanic Acid in pediatric patients. The study will compare a treatment group receiving the probiotic alongside antibiotics with a control group receiving antibiotics alone. The primary focus is on reducing antibiotic-induced intestinal discomfort through microbiota modulation.",[35],"NOT_YET_RECRUITING","2025-02-27",{"date":98,"type":40},"2025-03-04",{"date":100,"type":21},"2025-02-23",{"date":102,"type":21},"2025-12-31",{"name":104,"class":47},"Liaquat University of Medical & Health Sciences",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":18,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100517534","molecular-culture-for-the-diagnosis-of-pediatric-sepsis-100517534","NCT06018792","Molecular Culture for the Diagnosis of Pediatric Sepsis","Children's Health Assessment and Molecular Pathogen Identification for Optimized Novel Sepsis Therapy","CHAMPIONS","Inclusion Criteria:\n\n* Undergoing collection of blood for a conventional blood culture as part of standard care OR\n* Having undergone sepsis evaluation collection of blood for a conventional blood culture as part of standard care in the past 72 hours\n\nExclusion Criteria:\n\n* Apart from an age criterion, there are no strict exclusion criteria. However, for the analysis of the secondary outcome (I.e. the testing of diagnostic accuracy of both MC as well as conventional culture for clinical sepsis), we plan to exclude all children who ultimately have a clear alternative cause for clinical illness that does not directly result from bacteraemia or bacterial sepsis. This will remain true in the case of conventional culture positivity, either when considered a contaminant as well as when considered a contributing factor in the presence of any of the causes of clinical illness mentioned below. A potential subject who meets any of the following criteria will be excluded from participation in this study These causes include, but are not limited to:\n* In case of the potential inclusion of a neonate suspicious for EOS, confirmed congenital infection with TORCHES (toxoplasmosis, rubella, cytomegalovirus, syphilis and herpes) will lead to exclusion particularly for the neonatal population\n* Auto inflammatory disease\n* Hemophagocytic syndrome\n* SIRS (Systemic Inflammatory Response Syndrome following a severe viral infection","0 Years",{"count":116,"type":21},1835,"OBSERVATIONAL","Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the symptoms are often unclear and can also occur in children who are not sick. To determine whether there is an infection, a little blood is currently taken for a blood test (the blood culture) to investigate whether there is a bacteria in the blood. However, it often takes at least 36 hours before the results of this blood culture are available. That is why antibiotics are usually started immediately to treat the possible infection.\n\nHowever, it often turns out that the blood culture is negative after 36 hours, which means that no bacteria have been found in the blood. Usually the antibiotics are then stopped because it turns out that there was no infection at all. There is currently no good test that can predict whether (newborn) children have an infection or not. That is why too many children are currently wrongly receiving antibiotics. These antibiotics can damage the healthy bacteria in the intestines. There are many billions of 'beneficial bacteria' in the intestine. These play an important role in the digestion of food and protect against external infections. Antibiotics aim to kill bacteria that cause inflammation or infection. Unfortunately, antibiotics also kill some of these beneficial bacteria. In addition, unnecessary use of antibiotics contributes to antibiotic resistance. The aim of this research is to investigate whether Molecular Culture, a PCR based test that can identify bacterial pathogens in bodily fluids within 4 hours, has greater accuracy than traditional culturing techniques for bacteria in blood. If proven, this could lead to faster identification or exclusion of sepsis in children.",[120,121,122,123,35,124],"Sepsis","Sepsis Bacterial","Sepsis, Neonatal","Infection, Bacterial","Microbial Colonization","2024-04-09",{"date":127,"type":40},"2024-04-10",{"date":129,"type":40},"2024-03-10",{"date":131,"type":21},"2027-11-01",{"name":133,"class":47},"Jip Groen",2,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":105},"100535329","autoflor--lyophilized-capsulated-autological-fmt-to-restore-gut-microbiome-after-treatment-with-antibiotics-100535329","NCT06250413","Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics","Lyophilized Capsulated Autological Fecal Microbial Transplant to Restore Gut Microbiome After Treatment With Antibiotics","FMT","Inclusion Criteria:\n\n-previously healthy\n\nExclusion Criteria:\n\n* IBD (inflammatory bowel disease)\n* celiac disease\n* abdominal symptoms such as diarrhea or constipation necessitating medical therapy\n* pregnancy and breastfeeding\n* allergy towards antibiotics penicillins\n* allergy towards soya.\n* trehalose intolerance.\n* travelling outside of European Union during the last 3 months\n* use of antibiotics during the last 3 months\n* use of probiotics during the previous 2 weeks or during the study.","40 Years",{"count":145,"type":21},40,[92],"In this clinical trial, our aim is to assess the effect of auto-FMT (Fecal microbiome transplantation) on the intestinal microbiota, after a course of antibiotics.\n\n30 healthy adults are recruited. All are given a five day course of amoxicillin-clavulanate. The subjects are double blinded and randomized to two groups. Group A is given autologous FMT (auto-FMT) on day 7 (two days after the end of the course of antibiotics) and Group B is given auto-FMT on day 28 (23 days after the end of the course of antibiotics).",[124,35],[141,150,151],"lyophilized","antibiotics","2024-02-13",{"date":154,"type":40},"2024-02-14",{"date":156,"type":21},"2024-02",{"date":158,"type":21},"2027-12",{"name":160,"class":47},"Otto Helve"]