Eschar Investigations in Scrub Typhus

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

Conditions

• Scrub Typhus

Interventions

OTHER

Non-invasive eschar samples + blood

EXPa (n=12) will have blood and non-invasive eschar samples collected (consent to study, declined biopsy).

OTHER

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).

OTHER

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).

OTHER

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.

Sponsors & Collaborators

• Chiangrai Prachanukroh Hospital

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• Dr. Tri Wangrangsimakul, MD · Chiangrai Prachanukroh Hospital, Chiangrai, Thailand

Eligibility

Min Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-30

Primary Completion

2021-05-31

Completion

2021-05-31

Countries

• Thailand

Study Locations