Scrub TyphusQuESTNCT06675110
QuEST - Quick and Easy Scrub Typhus Diagnostic Tools
An observational study of Scrub Typhus, run by University of Oxford at 3 sites in Thailand.
Trial summary
Evaluate the performance of insulated isothermal polymerase chain reaction (iiPCR) in the diagnosis of scrub typhus in Chiang Rai Province Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Scrub Typhus
- How many people
- 345 participants
- Where
- 3 sitesThailand
- Study dates
- 17 Jul 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Febrile patients suspected of having scrub typhus and presenting to Mae Chan or Mae Suai district hospitals
Who may be able to join
- ≥ 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)
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Mae Fah Luang District Hospital
Chiang Rai
Mae Suai District Hospital
Chiang Rai
Mae Chan District Hospital
Mae Chan, Changwat Chiang Rai
About this study
Official title: Diagnostic Tools for the Direct Detection of Orientia Tsutsugamushi
Evaluate the performance of insulated isothermal polymerase chain reaction (iiPCR) in the diagnosis of scrub typhus in Chiang Rai Province
Read the detailed description
Screening and enrolment
The study team will screen patients presenting with fever at the out- and inpatient departments of study sites. A scrub typhus rapid diagnostic test (RDT) will be performed at all sites (e.g. Scrub Typhus IgM RDT, InBios International; Scrub Typhus IgM/IgA/IgG RDT, SDBioline; STANDARD Q Tsutsugamushi IgM/IgG, SDBiosensor) and insulated isothermal polymerase chain reaction (iiPCR) will be performed at Chiang Rai Clinical Research Unit (CCRU) central laboratories. Before being screened with any of the above tests for study purposes, potential participants will be asked to pre-consent to the screening test.
If participants have a positive screening test following an order form the treating physician as part of standard management (not for study purposes), this will be considered equivalent to a positive screening test; those subjects will be asked then to provide informed consent to participate in the study.
Eligible patients who agree to participate and/or their legal guardians will take part in the informed consent procedure. If the RDT or iiPCR test is positive for scrub typhus (one positive test is sufficient) or the patient has a fever and an eschar, the patient is formally enrolled into the study.
Every screened patient will receive a screening number and details are recorded into a screening log. Screening rejection is defined as patients who have been screened but are not enrolled into the study. Reasons for rejection may include any exclusion criteria, non-conformity with the inclusion criteria, or failure to obtain informed consent. Reasons will be recorded in the screening log. Patients who do not progress from screening to trial recruitment will not be assigned with a study number or have clinical data recorded in the screening log.
Inpatient stay Clinical review: Study patients will have their vital signs measured and recorded every 6 hours during hospitalisation. Details of antibiotics administered will be collected. Additional diagnostic test results (e.g. laboratory or imaging) requested by the medical team will also be collected and recorded on the case report from (CRF).
Patients admitted with scrub typhus to hospital for treatment will be discharged by the treating physician according to clinical improvement and resolution of fever.
Follow-up
Scheduled follow-up: A follow-up visits will occur at 2 weeks (+ 2 weeks). Examinations and samples are collected as outlined in the study flowchart (section 4.1.2 of the protocol).
If the patient cannot be followed-up, then the reason for loss-to-follow-up will be recorded on the CRF.
Study participants are asked to contact the study team if fever and/or symptoms and signs compatible with scrub typhus appear after hospital discharge until the patient exits the study (after the 2 week follow-up appointment). Clinical findings and samples are collected as outlined in the study flowchart.
If the patient was discharged or leaves the hospital prior to cessation of fever, the patient will be given a tympanic membrane monitor and asked to measure their temperature 4 times a day (flexible/pragmatic timings) and record the results in a diary until their fever has cleared. The diary and the thermometer will be collected by the study team at follow-up and the temperature readings used to calculate the fever clearance time.
The performance of RDTs and of iiPCR will be compared to that of reference quantitative PCR (qPCR) and indirect immunofluorescence assay (IFA) for the diagnosis of scrub typhus on acute and paired (acute and convalescent) samples. The test will also be compared to the modified scrub typhus infection criteria (Paris et al., 2011)
This study has been funded by Wellcome Trust. Grant number 315982/Z/24/Z
- Conditions
- Scrub Typhus
- Keywords
- Scrub typhus, Orientia tsutsugamushi, insulated isothermal PCR, diagnostic evaluation
- Medical subject headings
- Scrub Typhus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive- and negative predictive values of insulated isothermal polymerase chain reaction (iiPCR) compared to reference diagnostic tests
Measured: Baseline and week two
Secondary outcomes (2)
G6PD deficiency estimates
Measured: Week two
Risk exposure comparisons between healthy controls and scrub typhus cases
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start17 Jul 2024
- Primary completion31 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scrub TyphusStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Perrone, MD, Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675110
- Sponsor's protocol ID
- OxTREC Reference: 4 - 24
- Acronym
- QuEST
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of main findings, or 1 year after study completion (whichever comes first) and reasonable request to MORU data access committee
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Tools for the Direct Detection of Orientia Tsutsugamushi
- ClinicalTrials.gov ID
- NCT06675110
- Acronym / sponsor ID
- QuEST / OxTREC Reference: 4 - 24
- Conditions
- Scrub Typhus
- Keywords
- Scrub typhus, Orientia tsutsugamushi, insulated isothermal PCR, diagnostic evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the performance of insulated isothermal polymerase chain reaction (iiPCR) in the diagnosis of scrub typhus in Chiang Rai Province
Detailed description
Screening and enrolment
The study team will screen patients presenting with fever at the out- and inpatient departments of study sites. A scrub typhus rapid diagnostic test (RDT) will be performed at all sites (e.g. Scrub Typhus IgM RDT, InBios International; Scrub Typhus IgM/IgA/IgG RDT, SDBioline; STANDARD Q Tsutsugamushi IgM/IgG, SDBiosensor) and insulated isothermal polymerase chain reaction (iiPCR) will be performed at Chiang Rai Clinical Research Unit (CCRU) central laboratories. Before being screened with any of the above tests for study purposes, potential participants will be asked to pre-consent to the screening test.
If participants have a positive screening test following an order form the treating physician as part of standard management (not for study purposes), this will be considered equivalent to a positive screening test; those subjects will be asked then to provide informed consent to participate in the study.
Eligible patients who agree to participate and/or their legal guardians will take part in the informed consent procedure. If the RDT or iiPCR test is positive for scrub typhus (one positive test is sufficient) or the patient has a fever and an eschar, the patient is formally enrolled into the study.
Every screened patient will receive a screening number and details are recorded into a screening log. Screening rejection is defined as patients who have been screened but are not enrolled into the study. Reasons for rejection may include any exclusion criteria, non-conformity with the inclusion criteria, or failure to obtain informed consent. Reasons will be recorded in the screening log. Patients who do not progress from screening to trial recruitment will not be assigned with a study number or have clinical data recorded in the screening log.
Inpatient stay Clinical review: Study patients will have their vital signs measured and recorded every 6 hours during hospitalisation. Details of antibiotics administered will be collected. Additional diagnostic test results (e.g. laboratory or imaging) requested by the medical team will also be collected and recorded on the case report from (CRF).
Patients admitted with scrub typhus to hospital for treatment will be discharged by the treating physician according to clinical improvement and resolution of fever.
Follow-up
Scheduled follow-up: A follow-up visits will occur at 2 weeks (+ 2 weeks). Examinations and samples are collected as outlined in the study flowchart (section 4.1.2 of the protocol).
If the patient cannot be followed-up, then the reason for loss-to-follow-up will be recorded on the CRF.
Study participants are asked to contact the study team if fever and/or symptoms and signs compatible with scrub typhus appear after hospital discharge until the patient exits the study (after the 2 week follow-up appointment). Clinical findings and samples are collected as outlined in the study flowchart.
If the patient was discharged or leaves the hospital prior to cessation of fever, the patient will be given a tympanic membrane monitor and asked to measure their temperature 4 times a day (flexible/pragmatic timings) and record the results in a diary until their fever has cleared. The diary and the thermometer will be collected by the study team at follow-up and the temperature readings used to calculate the fever clearance time.
The performance of RDTs and of iiPCR will be compared to that of reference quantitative PCR (qPCR) and indirect immunofluorescence assay (IFA) for the diagnosis of scrub typhus on acute and paired (acute and convalescent) samples. The test will also be compared to the modified scrub typhus infection criteria (Paris et al., 2011)
This study has been funded by Wellcome Trust. Grant number 315982/Z/24/Z
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Febrile patients suspected of having scrub typhus and presenting to Mae Chan or Mae Suai district hospitals
Key inclusion criteria (7 listed)
- ≥ 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, specificity, positive- and negative predictive values of insulated isothermal polymerase chain reaction (iiPCR) compared to reference diagnostic tests
Time frame: Baseline and week two
2 secondary outcomes
G6PD deficiency estimates
Time frame: Week two
Risk exposure comparisons between healthy controls and scrub typhus cases
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. After publication of main findings, or 1 year after study completion (whichever comes first) and reasonable request to MORU data access committee
Related trials for Scrub Typhus
RecruitingPhase 2/3
Rickettsia Clearance Study
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Active, not recruitingPhase 4
Scrub Typhus Antibiotic Resistance Trial
Scrub Typhus
Active, not recruitingObservational study
Scrub Typhus Infection Induced Cardiovascular Disease
Scrub Typhus, Cardiovascular Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Perrone, MD principal investigator
Mahidol Oxford Tropical Medicine Research Unit
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scrub Typhus, run by University of Oxford at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, positive- and negative predictive values of insulated isothermal polymerase chain reaction (iiPCR) compared to reference diagnostic tests (time frame: Baseline and week two). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.