[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"typhoid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:typhoid":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100429936","transcriptomic-responses-for-the-identification-of-pathogens-100429936",false,"NCT04878549","Transcriptomic Responses for the Identification of Pathogens","A Multisite Evaluation of Functional Genomic Signatures for the Improved Diagnosis of Acute Undifferentiated Febrile Infections","TRiP","FEBRILE ADULTS- INCLUSION CRITERIA\n\n* Age greater than or equal to 15 years and less than or equal to 65 years\n* Participant is willing and they and\u002For an appropriate guardian\u002Frelative\u002Frepresentative is able to give informed consent for participation in the study and a follow-up (telephone) discussion at 14 days\n* And either:\n\n  1. Febrile illness without localising features (see 'exclusion criteria' and 'screening' sections) where fever is defined as:\n\n     * documented tympanic\u002Frectal temperature of ≥ 38°C or an axillary\u002Foral temperature of ≥ 37.8°C, or a reported fever within the last 24 hours and\n     * Reported duration of fever 3-14 days or\n  2. Recently confirmed blood culture indicating enteric fever (confirmed within the previous 5 days)\n* They may have had recent exposure to antimicrobials.\n\nFEBRILE ADULTS- EXCLUSION CRITERIA\n\n* The participant may not enter the study if ANY of the following apply:\n* Unable to provide informed consent and no next of kin is willing and able to provide informed consent.\n* For patients with febrile illness (included in (1) above): Any history or clinical suspicion of:\n\n  * Rheumatological or connective tissue disorder (e.g. Rheumatoid arthritis)\n  * Autoimmune condition (e.g. Autoimmune Hepatitis)\n  * Malignancy\n  * Active treatment with immunomodulating medications, or for tuberculosis (pulmonary or extrapulmonary) or any other chronic infection.\n* Pregnancy (breast feeding mothers will NOT be excluded)\n* No hospitalisation for more than 48 hours in the last 4 weeks\n* Vaccination within 4 weeks prior to current admission\n* Localising signs or symptoms of infection sufficient to diagnose the likely cause of acute febrile illness and thus prevent it from being 'undifferentiated.'\n\nCONTROLS- INCLUSION CRITERIA\n\n* Participant is willing and they are (and in 15-18 year olds, a guardian is) able to give informed consent for participation in the study\n* Age greater than or equal to 15 years and less than or equal to 65 years\n* They live outside of the normal\u002Flocal catchment area for each hospital site\n* Afebrile (as defined by no reported fever and temperature ≤ 38°C or an axillary\u002Foral temperature of ≤ 37.8°C).\n\nCONTROLS- EXCLUSION CRITERIA\n\n* The participant may not enter the study if ANY of the following apply:\n* Unable to provide informed consent and no next of kin (or parent\u002Fguardian in the case of a minor) is willing and able to provide informed consent.\n* Current treatment for or prior history, or clinical suspicion of:\n\n  * Rheumatological or connective tissue disorder\n  * Autoimmune condition\n  * Malignancy\n  * Active treatment for tuberculosis (pulmonary or extrapulmonary) or clinical suspicion of active tuberculosis. Previous completed treatment is not a reason for exclusion.\n  * Active treatment with immunomodulating medications or any other chronic infection.\n* Pregnant (breast feeding mothers will NOT be excluded)\n* Hospitalisation within 4 weeks of recruitment\n* Vaccination within 4 weeks prior to recruitment\n* Antimicrobial use within 4 weeks of recruitment\n* Participant reports feeling more unwell than usual on the day of enrolment.\n\nEXPLORATORY AIMS- PAEDIATRIC CRITERIA; INCLUSION CRITERIA\n\n* Age greater than or equal to 2 years and less than 15 years\n* As above for adult participants.\n\nEXPLORATORY AIMS- PAEDIATRIC CRITERIA; EXCLUSION CRITERIA\n\n* Parent\u002Fguardian is unwilling, and\u002For patient aged 8 to 14 years is unwilling to assent to provide informed consent.\n* As above for adult participants.",true,"ALL","2 Years","65 Years",{"count":22,"type":23},2000,"ESTIMATED","14 Days","OBSERVATIONAL","Acute undifferentiated febrile infection (AUFI) is a common presenting syndrome in low-resource settings and better diagnostics are urgently needed to improve patient management and guide disease prevention interventions. Assessment of the host gene expression response to infection in endemic populations has demonstrated significant promise as a new approach to identifying patients with enteric fever and for potential in differentiating between other causes of AUFI. Signatures identified through new data analytic techniques could be developed into a point-of-care test for use in endemic settings.\n\nIn this multisite diagnostic evaluation study we will collect prospective clinical, laboratory and diagnostic data from two endemic settings to evaluate host gene expression signatures for detecting enteric fever and for determining the cause of AUFI in LMIC settings.",[28,29,30,31,32],"Enteric Fever","Acute Febrile Illness","Typhoid","Paratyphoid Fever","Fever",[34,35],"Gene Expression Profiling","RNA-Seq","RECRUITING","2025-02-26",{"date":39,"type":40},"2025-03-03","ACTUAL",{"date":42,"type":40},"2022-05-02",{"date":44,"type":23},"2025-06",{"name":46,"class":47},"University of Sheffield","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":48},"100574284","phase-3-zyvac-tcv-bangladesh-study-100574284","NCT06757283","ZyVac-TCV Bangladesh Study","Evaluation of Typhoid Conjugate Vaccine (TCV) Effectiveness Among Bangladeshi Children Using the Test-negative Design","Inclusion Criteria:\n\n* Participant was included in the baseline list of the study population\n* Participants living within the study catchment area at the time of vaccination\n* Parent\u002Fguardian is willing and competent to provide informed consent (if the participant is 11 to 15 years of age, assent will also be sought)\n* Participants aged between 6 months to15 years (i.e. up to 15 years 364 days) at the time of vaccination\n* Apparently healthy (no complaints of febrile illness) on the day of vaccination\n* Parent\u002Fguardian confirms that their child will be willing and be able to comply with study requirements\n\nExclusion Criteria:\n\n* Has knowingly received a typhoid vaccine in the past\n* Known allergy to any vaccine in the past\n* Medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional\n* Planning to move away from the catchment area within the next 12 months\n* Pregnant at the time of vaccination, as confirmed by a urine test (urine pregnancy test will be done in girls who are married)\n* Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy\n* Subject participated in another clinical study in the past 3 months","6 Months","15 Years",{"count":59,"type":23},4000,"INTERVENTIONAL",[62],"PHASE3","This is a prospective closed cohort, open-label, phase III effectiveness study using a test-negative design of a typhoid conjugate vaccine, ZyVac® TCV (purified Vi capsular polysaccharide of Salmonella Typhi conjugated to tetanus toxoid as carrier protein), manufactured by Zydus Lifesciences Limited. The study will be conducted in a closed cohort population among children aged 6 months to 15 years residing in wards 5, 6, 7, 48, 49, 50, 63, 71, and 72 of Dhaka South City Corporation (DSCC). The targeted number of age-eligible children in the study area is \\~92,000 among them \\~60,000 will be vaccinated. A subset of the first 600 consenting participants will be selected by age strata (6 months to \\\u003C2 years, 2-4 years, 5-15 years) for enrollment in the immunogenicity study with an additional three follow-up visits. Diary cards will be used to collect adverse events (AEs) following immunization (AEFI) data up to day 7 for a subset of active follow-up of the first 600 vaccinated participants. Participants not in this subset will be encouraged to go to the 'Adverse Event Monitoring Cell' at the Maniknagar field office. Data on serious adverse events (SAEs) will be reported for six months after vaccination. All study updates including AEs and SAEs will be reported to the data safety and monitoring board (DSMB) and sponsor. Passive surveillance for typhoid fever will be carried out in the Maniknagar field office and Mugda Medical College and Hospital in the catchment area among the age-eligible children.",[65,30,66],"Typhoid Vaccination","Typhoid Fever",[68,69,70,71,72,73],"Conjugate vaccine","Immunogenicity","Safety","Typhoid fever","Bangladesh","Children","NOT_YET_RECRUITING","2025-02-06",{"date":77,"type":40},"2025-02-07",{"date":79,"type":23},"2025-04-01",{"date":81,"type":23},"2026-05-30",{"name":83,"class":47},"International Centre for Diarrhoeal Disease Research, Bangladesh"]