CompletedNot Applicable

Eschar Investigations in Scrub Typhus

Thailand44 participantsStarted 2017-06-30

Plain-language summary

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. 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

Who can participate

Age range7 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Scrub Typhus Patients (EXP) inclusion criteria: * Age ≥7 years old. * 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). Scrub Typhus Controls (EXC) inclusion criteria: * 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). Scrub Typhus Patients (EXP) exclusion criteria: * Current TB or TB treatment in ≤6 months (contains OT-effective antimicrobials) * Documented HIV infection, use of steroids, chemotherapy, other immunosuppressants, or herbal remedies containing steroids, and/or pregnancy Scrub Typhus Controls (EXC) exclusion criteria: * Significant acute intercurr…

What they're measuring

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

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

Trial details

NCT IDNCT02915861

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-05-31

View on ClinicalTrials.gov More Scrub Typhus trials

Plain-language summary

Who can participate

Age range7 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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