Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2017-06-30
2021-05-31
Brief Summary
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In this study, we aim to:
* 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).
* 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.
* 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.
Data sharing:
No 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
* Any requests for data sharing will be considered by MORU's data sharing committee
* Any data subsequently shared will be anonymised and will not include personal identifiers
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Detailed Description
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* EXPa (n=12) will have blood and non-invasive eschar samples collected (consent to study, declined biopsy).
* EXPb (n=12) will have blood, non-invasive eschar samples, and an eschar biopsy collected (consent to study, draining lymph node (LN) inaccessible).
* EXPc (n=12) will have blood, non-invasive eschar samples, eschar biopsy, and LN FNA collected (consent to study, draining LN accessible).
Samples will be collected at baseline (all) and 2 weeks (blood only).
Control participants will be recruited into the scrub typhus control.
\- 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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EXPa
Scrub typhus patients: Group A
Non-invasive eschar samples + blood
EXPa (n=12) will have blood and non-invasive eschar samples collected (consent to study, declined biopsy).
EXPb
Scrub typhus patients: Group B
Non-invasive eschar samples+eschar biopsy+blood
EXPb (n=12) will have blood, non-invasive eschar samples, and an eschar biopsy collected (consent to study, draining LN inaccessible).
EXPc
Scrub typhus patients: Group C
Non-invasive eschar samples+eschar biopsy+lymph node fine-needle aspiration biopsy+blood
EXPc (n=12) will have blood, non-invasive eschar samples, eschar biopsy, and LN FNA collected (consent to study, draining LN accessible).
EXC
Control group
Blood+Skin sample
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.
Interventions
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Non-invasive eschar samples + blood
EXPa (n=12) will have blood and non-invasive eschar samples collected (consent to study, declined biopsy).
Non-invasive eschar samples+eschar biopsy+blood
EXPb (n=12) will have blood, non-invasive eschar samples, and an eschar biopsy collected (consent to study, draining LN inaccessible).
Non-invasive eschar samples+eschar biopsy+lymph node fine-needle aspiration biopsy+blood
EXPc (n=12) will have blood, non-invasive eschar samples, eschar biopsy, and LN FNA collected (consent to study, draining LN accessible).
Blood+Skin sample
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.
Eligibility Criteria
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Inclusion Criteria
* Presentation to hospital with fever in ≤14 days and a clinical suspicion of typhus.
* Eschar observed on examination.
* Scrub typhus RDT positive or OT qPCR positive (if qPCR available at local site by time of study initiation).
* 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).
* Age ≥7 years old.
* Clinically well, attending elective/minor surgery or for treatment of minor skin injury.
* 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.
* 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).
Exclusion Criteria
* Documented HIV infection, use of steroids, chemotherapy, other immunosuppressants, or herbal remedies containing steroids, and/or pregnancy
* Significant acute intercurrent illness at the time of admission including fever \>37.5˚C or infection (including TB) requiring antibiotics
* Documented HIV infection, use of steroids, chemotherapy, other immunosuppressants, or herbal remedies containing steroids, and/or pregnancy
7 Years
ALL
No
Sponsors
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Chiangrai Prachanukroh Hospital
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Dr. Tri Wangrangsimakul, MD
Role: PRINCIPAL_INVESTIGATOR
Chiangrai Prachanukroh Hospital, Chiangrai, Thailand
Locations
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Chiangrai Prachanukroh Hospital
Chiang Rai, , Thailand
Countries
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Other Identifiers
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MICRO1504
Identifier Type: -
Identifier Source: org_study_id
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