NCT02915861: EXIST

Eschar Investigations in Scrub Typhus

Completed Last updated 5 August 2021

What this trial tests

trial testing Non-invasive eschar samples + blood in Scrub Typhus in 44 participants. Completed in 31 May 2021.

Timeline

30 June 2017

Primary endpoint
31 May 2021

31 May 2021

Quick facts

Lead sponsor	University of Oxford
Status	Completed
Study type	OBSERVATIONAL
Enrollment	44
Start date	30 June 2017
Primary completion	31 May 2021
Estimated completion	31 May 2021
Sites	1 location across Thailand

Drugs / interventions tested

• Non-invasive eschar samples + blood
• Non-invasive eschar samples+eschar biopsy+blood
• Non-invasive eschar samples+eschar biopsy+lymph node fine-needle aspiration biopsy+blood
• Blood+Skin sample

Conditions studied

• Scrub Typhus — all drugs for Scrub Typhus →

Sponsor

University of Oxford

Who can join

7 and older, any sex, with Scrub Typhus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Molecular diagnosis and genotyping of <i>Orientia tsutsugamushi</i> in Maesot and Chiangrai, Thailand.
   Rungrojn A, Batty EM, Perrone C, Abdad MY, et al · · 2023 · cited 8× · PMID 39376595 · DOI 10.3389/fitd.2023.1146138
2. The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study.
   Greer RC, Kanthawang N, Roest J, Perrone C, et al · · 2023 · cited 3× · PMID 38115021 · DOI 10.1186/s12910-023-00991-0
3. Vulnerability and agency in research participants' daily lives and the research encounter: A qualitative case study of participants taking part in scrub typhus research in northern Thailand.
   Greer RC, Kanthawang N, Roest J, Wangrangsimakul T, et al · · 2023 · cited 3× · PMID 36696400 · DOI 10.1371/journal.pone.0280056