Table 1.
Linked scrub typhus study details
| Study details | ||
|---|---|---|
| Study title | The Scrub Typhus Antibiotic Resistance Trial comparing doxycycline and azithromycin treatment modalities in areas of reported antimicrobial resistance for scrub typhus | Eschar investigations to improve diagnostics, understand early immune responses and characterize strains for vaccines in scrub typhus |
| Study design | Randomized controlled trial (RCT) | Observational |
| Aims | Determine the optimum treatment for scrub typhus by comparing three oral antibiotic treatments | Improve understanding of the immune response to scrub typhus and investigate possible early diagnostics |
| Study population | Patients ≥ 15 years old hospitalised with non-severe scrub typhus |
• ≥ 7 years old AND • Patients presenting to hospital with scrub typhus OR • Controls with skin injuries or attending minor surgery, who have had scrub typhus in the past or live in an endemic area. |
| Study processes |
• Randomised to 1 of 3 treatment arms • Demographic & clinical data • Blood & urine samples at enrolment • Daily clinical review while in hospital • A further 6 or 12 blood samples over the next week • Follow up at 2 and 8 weeks (clinical data, blood & urine samples) |
Patients: • Demographic & clinical data • Eschar swabs, scrapings or biopsies • Lymph node aspirates from a subgroup • Blood & urine samples at enrolment • Follow up at 2 weeks (clinical data, blood & urine samples) Controls: • Demographic & clinical data • Blood & urine samples at enrolment • Skin biopsies |
| Study benefits |
• Treatment for scrub typhus (although most would be entitled to free treatment as part of routine care) • Compensation for time and reimbursement for actual travel costs for enrolment and follow-up visits • May help to improve scrub typhus treatment in the future |
• No direct benefits • Compensation for time and reimbursement for actual travel costs for enrolment and follow-up visits • May increase understanding of scrub typhus disease severity and diagnostics |
| ClinicalTrials.gov identifier | NCT03083197 | NCT02915861 |
Adapted from Greer et al. 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. PLoS One. 2023;18(1):e0280056. Epub 2023/01/26. doi: 10.1371/journal.pone.0280056. License CC BY [6]