[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"therapeutics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:therapeutics":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100513999","phase-2-rickettsia-clearance-study-100513999",false,"NCT05972772","Rickettsia Clearance Study","A Pharmacokinetic-pharmacodynamic Study of Early Rickettsia Clearance in Murine Typhus or Scrub Typhus Patients Treated with Doxycycline or Azithromycin","RiCS","Inclusion Criteria:\n\n* Age above or equal 18 years\n* Able to take oral medication\n* Rapid test positive for murine typhus or scrub typhus\n* Agrees to stay in hospital for at least 36 hours and to attend for scheduled follow up visits\n* Written informed consent to participate in the study\n* A negative urinary pregnancy test for all women of child-bearing age\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Previous allergic reaction to doxycycline or azithromycin\n* Received more than one dose of chloramphenicol, doxycycline, tetracycline, fluoroquinolones, rifampicin or azithromycin during this hospital admission or more than one dose of any of these drugs in the week before admission\n* Contraindication to doxycycline: severe hepatic impairment, known SLE\n* Contraindication to azithromycin: sever hepatic impairment\n* Severe typhus defined as the presence of one or more of the following:\n\n  1. Reduced level of consciousness\n  2. Clinical jaundice\n  3. Shock (BP systolic \\\u003C80 mmHg)\n  4. Unable to take oral medication\n  5. Radiological evidence of pneumonia\n  6. Clinical evidence for meningitis\u002Fencephalitis or the need of LP\n  7. Alternative diagnosis confirmed that explains the presenting symptoms\n  8. Any other syndrome which in the opinion of the admitting doctor constitutes severe typhus (reason must be stated)",true,"ALL","18 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","Murine typhus is a disease caused by Rickettisa typhi, an obligate intracellular bacterium transmitted by rodent fleas. The disease has a worldwide distribution; however the true burden is unknown, related to its non-specific presentation and lack of access to diagnosis in many regions. A systematic review of untreated murine typhus based on observational studies of a total of 239 patients has estimated the mortality associated with the disease at between 0.4% and 3.6%.\n\nScrub typhus is caused by Orientia tsutsugamushi and transmitted by the larval stage of chigger mites (Trombiculidae family). It has been estimated to affect at least one million people each year. A systematic review found varying reports of the mortality associated with untreated scrub typhus ranging from 0-70% (median 6%).\n\nPolymerase chain reaction (PCR) based diagnosis of rickettsial infections is only available in one centre (Mahosot Hospital) in Vientiane. A number of hospitals use a variety of point-of-care antibody tests to diagnose rickettsial infections however many of these have not been validated and they are of uncertain sensitivity and specificity. In 2006 results of a two year prospective study of 427 patients presenting to Mahosot Hospital with a febrile illness and negative blood cultures showed that 115 (27%) patients had an acute rickettsial infection, confirmed by serological testing. Among these patients, 41 were diagnosed with murine typhus and 63 with scrub typhus. Antibacterial agents with activity against rickettsial pathogens include doxycycline, azithromycin, chloramphenicol and rifampicin. Azithromycin is often reserved for pregnant women or children below the age of 8 years due to lasting concerns after the tetracycline-associated staining of growing bones and teeth in the past. Evidence is accumulating that doxycycline is superior to azithromycin for the treatment of rickettsial disease. Clinical treatment failures have occurred following azithromycin treatment of murine typhus. The relationship between rickettsial bacteria load and both disease severity and response to treatment has not been characterised. Rickettsial concentrations in blood are generally low, of the order of 210 DNA copies\u002FmL blood for R. typhi and 284 DNA copies\u002FmL blood for O. tsutsugamushi. At present, there is no standard antibiotic susceptibility testing (AST) method for R. typhi and O. tsutsugamushi. The gold standard method for AST for Rickettsia pathogens is the plaque assay which determines minimal inhibitory concentration (MICs) from the smallest antimicrobial concentration inhibiting rickettsial plaque forming unit formation. This method is laborious and time consuming, taking approximately 14-16 days based on species to yield a result. Molecular detection methods are useful for diagnosing patients infected with rickettsial pathogens and has been applied for antibiotic susceptibility testing. Antibiotic susceptibility testing based on DNA synthesis inhibition detecting by quantitative PCR (qPCR) for O. tsutsugamushi clinical isolates has been reported. However, the relationship between antibiotic susceptibility profiles and treatment response has not been studied. There is a need to develop a reliable ex vivo method to characterize the treatment response and compare susceptibility of R. typhi and O. tsutsugamushi to different agents.",[29,30],"Infectious Disease","Therapeutics",[32,33],"Scrub Typhus","Typhus, Endemic Flea-Borne","RECRUITING","2024-12-23",{"date":37,"type":38},"2024-12-27","ACTUAL",{"date":40,"type":38},"2024-11-01",{"date":42,"type":22},"2026-08-31",{"name":44,"class":45},"Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100520900","phase-4-clinical-observation-and-mechanism-study-of-yunnan-baiyao-in-different-stages-of-diabetic-foot-100520900","NCT06062576","Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot","Clinical Efficacy Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot","Inclusion Criteria:\n\n1. The age of the subjects is 18-80 years old;\n2. Diagnose diabetes according to WHO standards;\n3. Diagnosis of Diabetic foot;\n4. Confirmed as one of the stages of infection progression and granulation growth;\n5. Voluntarily participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;\n2. Blood glucose is out of control, Glucose test#Fasting blood sugar\\&gt;15mmol \u002FL, Glycated hemoglobin\\&gt;12%;\n3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;\n4. Serum albumin\\&lt;20g\u002FL; Hemoglobin\\&lt;60g\u002FL; Platelets\\&lt;50 × 109\u002FL;\n5. Late stage subjects with malignant tumors;\n6. Active period of autoimmune diseases;\n7. Have a history of allergy to Yunnan Baiyao;\n8. The subject is unable to cooperate or has mental disorders;\n9. According to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.","80 Years",{"count":55,"type":22},100,[57],"PHASE4","Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. This study explored the possible indications and use methods of Yunnan Baiyao in different stages of Diabetic foot, and obtained Evidence-based medicine evidence of clinical efficacy. Obtain the discarded tissues of Diabetic foot patients in the treatment and control groups of Yunnan Baiyao after wound debridement, conduct Transcriptome (BulkRNA seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of Yunnan Baiyao.",[60,30],"Diabetic Foot",[60,30],"2024-06-21",{"date":64,"type":38},"2024-06-25",{"date":66,"type":38},"2023-12-01",{"date":68,"type":22},"2025-06-30",{"name":70,"class":45},"Peking University Third Hospital",1]