QuEST - Quick and Easy Scrub Typhus Diagnostic Tools

NCT06675110 | Completed

• 1 other identifier: OxTREC Reference: 4 - 24
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 3

Brief Summary

Evaluate the performance of insulated isothermal polymerase chain reaction (iiPCR) in the diagnosis of scrub typhus in Chiang Rai Province

Conditions

Scrub Typhus

Keywords

Scrub typhus; Orientia tsutsugamushi; insulated isothermal PCR; diagnostic evaluation

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity, positive- and negative predictive values of insulated isothermal polymerase chain reaction (iiPCR) compared to reference diagnostic tests

  Baseline and week two

Secondary Outcomes (2)

• G6PD deficiency estimates

  Week two

• Risk exposure comparisons between healthy controls and scrub typhus cases

  Baseline

Study Arms (1)

Suscpected scrub typhus cases

Participants with symptoms and epidemiologic risks for of scrub typhus and testing positive by: 1. StandardQ rapid diagnostic test OR 2. InBios Scrub Typhus Detect IgM 3. Insulated isothermal PCR

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Febrile patients suspected of having scrub typhus and presenting to Mae Chan or Mae Suai district hospitals

You may qualify if:

• ≥ 7 years old AND
• Weight\>15Kg AND
• The patient and/or where relevant their parent/guardian/caretaker/LAR willing and able to give informed consent /assent for participation in the study AND
• Acute (duration ≤14 days) fever (37.5°C or higher or a history of fever in the previous 24h)
• For study group • Eschar OR Positivity to any of the screening tests (Immunochromatographic RDT or iiPCR)
• For negative control
• Negativity to all screening tests (ten patients per hospital)

You may not qualify if:

• Other clear focus of infection (e.g. lobar pneumonia by chest x-ray, abscess) OR
• Other clear cause of fever (e.g. positive Dengue IgM or NS1 antigen, positive blood cultures, untreated HIV)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (3)

Mae Chan District Hospital

Mae Chan, Changwat Chiang Rai, Thailand

Location

Mae Fah Luang District Hospital

Chiang Rai, Thailand

Location

Mae Suai District Hospital

Chiang Rai, Thailand

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood in EDTA and clotted blood

MeSH Terms

Conditions

Scrub Typhus

Condition Hierarchy (Ancestors)

Rickettsiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Study Officials

• Carlo Perrone, MD

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: July 17, 2024
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TH (3)