Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-01-11 @ 11:58 AM
Study NCT ID:
NCT02915861
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eschar Investigations in Scrub Typhus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012612', 'term': 'Scrub Typhus'}], 'ancestors': [{'id': 'D012288', 'term': 'Rickettsiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Non-invasive eschar samples\n2. Eschar biopsy\n3. Lymph node fine-needle aspiration biopsy (LN FNA)\n4. Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phenotypic characterisation of the major subset of Orientia tsutsugamushi (OT) infected leucocytes within eschar, lymph node, and blood during the dissemination phase of OT in vivo.', 'timeFrame': '2 years'}, {'measure': 'Characterisation of cytokine and RNA gene expression profiles within the eschar, lymph node, and blood in vivo and comparisons with profiles of uninfected target cells.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Establishing the usefulness of non-invasive eschar samples from patients with acute scrub typhus for diagnostics for OT and for genotyping +/- whole-genome sequencing.', 'timeFrame': '2 years'}, {'measure': 'Define and contrast the eschar histo-pathological findings in this study in Thailand to previous findings from Laos, where the Gilliam strain predominates.', 'timeFrame': '2 years'}, {'measure': 'Comparisons to parallel studies in the non-human primate model with emphasis on dissemination dynamics, immunomodulation, and the innate and adaptive immune responses to OT; contributing to vaccine development.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immune responses', 'vaccines'], 'conditions': ['Scrub Typhus']}, 'descriptionModule': {'briefSummary': "This is an observational study of patients with scrub typhus (rapid diagnostic test/quantitative polymerase chain reaction (RDT/qPCR) positive) and an inoculation eschar present on examination, recruited from Chiangrai Prachanukroh Hospital, North of Thailand.\n\nIn this study, we aim to:\n\n* Investigate relevant pathogen dissemination dynamics, early innate immune response, and pathogen-host interactions in scrub typhus using a minimal set of easily accessible samples; the inoculation eschar (crust or biopsy), whole blood and - where possible - a lymph node fine-needle aspiration (FNA).\n* Determine the potential use of the inoculation eschar for improving early diagnostics and assessing the diversity of human pathogenic strains; by evaluating non-invasive swabs and scrapings, as well as biopsies for molecular diagnostics templates.\n* Dissect the underlying patho-biology associated with the inoculation eschar and in a subgroup, including the draining lymph node; by defining the spectrum of infected cells via microscopy and double-immune labeling; by determining cytokine and RNA gene expression profiles in blood peripheral blood mononuclear cell (PBMCs) and eschar samples.\n\nData sharing:\n\nNo future analysis or study of legacy data/specimens including data sharing for purposes not specified in the protocol will be done without seeking further regulatory (EC/IRB) approval\n\n* Any requests for data sharing will be considered by MORU's data sharing committee\n* Any data subsequently shared will be anonymised and will not include personal identifiers", 'detailedDescription': 'Scrub typhus patients will be recruited into the scrub typhus patient (EXP) arm of the study. There will be 3 sub-groups:\n\n* EXPa (n=12) will have blood and non-invasive eschar samples collected (consent to study, declined biopsy).\n* EXPb (n=12) will have blood, non-invasive eschar samples, and an eschar biopsy collected (consent to study, draining lymph node (LN) inaccessible).\n* EXPc (n=12) will have blood, non-invasive eschar samples, eschar biopsy, and LN FNA collected (consent to study, draining LN accessible).\n\nSamples will be collected at baseline (all) and 2 weeks (blood only).\n\nControl participants will be recruited into the scrub typhus control.\n\n\\- EXC (n=12) are healthy individuals, attending hospital for elective/minor surgery or treatment of minor skin injury, and normally reside in a scrub typhus endemic region. Blood and a skin sample will be collected at baseline only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'EXP: Male and female patients ≥7 years old with confirmed acute scrub typhus and an eschar present on examination (N=36).\n\nEXC: Healthy individuals ≥7 years old who normally reside in a scrub typhus endemic region, attending hospital for elective/minor surgery or treatment of minor skin injury, and preferably age and sex-matched (N=12).', 'healthyVolunteers': False, 'eligibilityCriteria': "Scrub Typhus Patients (EXP) inclusion criteria:\n\n* Age ≥7 years old.\n* Presentation to hospital with fever in ≤14 days and a clinical suspicion of typhus.\n* Eschar observed on examination.\n* Scrub typhus RDT positive or OT qPCR positive (if qPCR available at local site by time of study initiation).\n* Willingness to participate in the study. Written informed consent obtained from the patient (≥18 years old) or, written informed assent from participant (≥7 to \\<18years old) along with written informed consent from participant's parent(s)/legal guardian(s).\n\nScrub Typhus Controls (EXC) inclusion criteria:\n\n* Age ≥7 years old.\n* Clinically well, attending elective/minor surgery or for treatment of minor skin injury.\n* Historical diagnosis of scrub typhus (RDT, serology, and/or PCR positivity) more than 2 years ago or living in an endemic area with high risk of previous exposure.\n* Willingness to participate in the study. Written informed consent obtained from the patient (≥18 years old) or written informed assent from participant (≥7 to \\<18years old) along with written informed consent from participant's parent(s)/legal guardian(s).\n\nScrub Typhus Patients (EXP) exclusion criteria:\n\n* Current TB or TB treatment in ≤6 months (contains OT-effective antimicrobials)\n* Documented HIV infection, use of steroids, chemotherapy, other immunosuppressants, or herbal remedies containing steroids, and/or pregnancy\n\nScrub Typhus Controls (EXC) exclusion criteria:\n\n* Significant acute intercurrent illness at the time of admission including fever \\>37.5˚C or infection (including TB) requiring antibiotics\n* Documented HIV infection, use of steroids, chemotherapy, other immunosuppressants, or herbal remedies containing steroids, and/or pregnancy"}, 'identificationModule': {'nctId': 'NCT02915861', 'acronym': 'EXIST', 'briefTitle': 'Eschar Investigations in Scrub Typhus', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Eschar Investigations to Improve Diagnostics, Understand Early Immune Responses and Characterize Strains for Vaccines in Scrub Typhus', 'orgStudyIdInfo': {'id': 'MICRO1504'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EXPa', 'description': 'Scrub typhus patients: Group A', 'interventionNames': ['Other: Non-invasive eschar samples + blood']}, {'label': 'EXPb', 'description': 'Scrub typhus patients: Group B', 'interventionNames': ['Other: Non-invasive eschar samples+eschar biopsy+blood']}, {'label': 'EXPc', 'description': 'Scrub typhus patients: Group C', 'interventionNames': ['Other: Non-invasive eschar samples+eschar biopsy+lymph node fine-needle aspiration biopsy+blood']}, {'label': 'EXC', 'description': 'Control group', 'interventionNames': ['Other: Blood+Skin sample']}], 'interventions': [{'name': 'Non-invasive eschar samples + blood', 'type': 'OTHER', 'description': 'EXPa (n=12) will have blood and non-invasive eschar samples collected (consent to study, declined biopsy).', 'armGroupLabels': ['EXPa']}, {'name': 'Non-invasive eschar samples+eschar biopsy+blood', 'type': 'OTHER', 'description': 'EXPb (n=12) will have blood, non-invasive eschar samples, and an eschar biopsy collected (consent to study, draining LN inaccessible).', 'armGroupLabels': ['EXPb']}, {'name': 'Non-invasive eschar samples+eschar biopsy+lymph node fine-needle aspiration biopsy+blood', 'type': 'OTHER', 'description': 'EXPc (n=12) will have blood, non-invasive eschar samples, eschar biopsy, and LN FNA collected (consent to study, draining LN accessible).', 'armGroupLabels': ['EXPc']}, {'name': 'Blood+Skin sample', 'type': 'OTHER', 'description': 'Controls (EXC, n=12) are healthy individuals, attending hospital for elective/minor surgery or treatment of minor skin injury, and normally reside in a scrub typhus endemic region. Blood and a skin sample will be collected at baseline only.', 'armGroupLabels': ['EXC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiang Rai', 'country': 'Thailand', 'facility': 'Chiangrai Prachanukroh Hospital', 'geoPoint': {'lat': 19.90858, 'lon': 99.8325}}], 'overallOfficials': [{'name': 'Dr. Tri Wangrangsimakul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiangrai Prachanukroh Hospital, Chiangrai, Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chiangrai Prachanukroh Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}