Evaluating new diagnostic tools for scrub typhus
Diagnostic Tools for the Direct Detection of Orientia Tsutsugamushi
This study is testing a new way to quickly and accurately diagnose scrub typhus in patients with fever in Chiang Rai Province.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Mae Chan, Chiang Rai) |
| Trial ID | NCT06675110 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of insulated isothermal polymerase chain reaction (iiPCR) for diagnosing scrub typhus in patients presenting with fever in Chiang Rai Province. Patients will undergo screening with rapid diagnostic tests (RDTs) and iiPCR to confirm the presence of scrub typhus. The study will enroll individuals who meet specific clinical criteria, including fever duration and symptoms, and will collect data on their diagnostic outcomes. The goal is to improve the accuracy and speed of scrub typhus diagnosis in endemic areas.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 7 years and older with acute fever and specific clinical signs indicative of scrub typhus.
Not a fit: Patients with clear alternative causes of fever or other infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnosis of scrub typhus, improving patient outcomes and treatment efficacy.
How similar studies have performed: Other studies have shown promise in using advanced diagnostic techniques for scrub typhus, but the specific application of iiPCR in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute (duration ≤14 days) fever (37.5°C or higher or a history of fever in the previous 24h) AND * Eschar OR * ≥ 2 of the following: * Living in rural parts of Chiangrai Province or other ST risk areas * History of outdoor risk activities in the 2 weeks before symptom onset * Presenting during the rainy season or early cold season * Two or more of: headache; myalgia, cough, abdominal symptoms (abdominal pain/ nausea-vomiting); myalgia; lymphadenopathy AND * ≥ 7 years old AND * Weight\>15Kg AND * The patient and/or where relevant their parent/guardian/caretaker/legally acceptable representative willing and able to give informed consent /assent for participation in the study AND Positivity to any of the screening tests (Immunochromatographic RDT or iiPCR) Exclusion Criteria: - 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)
Where this trial is running
Mae Chan, Chiang Rai
- Mae Chan District Hospital — Mae Chan, Chiang Rai, Thailand (Recruiting)
Study contacts
- Principal investigator: Carlo Perrone, MD — Mahidol Oxford Tropical Medicine Research Unit
- Study coordinator: Carlo Perrone, MD
- Email: carlo@tropmedres.ac
- Phone: +66 5202 9842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.