Table 1 Linked scrub typhus 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