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Scrub Typhus Antibiotic Resistance Trial
Sponsor: University of Oxford
Summary
Study type: Randomized Control Treatment Trial Study population: Male and female patients with ≥15 years of age and acute scrub typhus Duration: 2 years Study Design: Prospective, open-label, randomized-controlled treatment trial in patients ≥15 years old admitted to hospital with acute scrub typhus. Randomization into 3 oral treatment arms (each n=59 patients, total n=177): i) 7 days of doxycycline, ii) 3 days of doxycycline, and iii) 3 days of azithromycin Primary Objective: To evaluate the clinical and microbiological responses in scrub typhus patients to three oral treatment regimens: 7 days of doxycycline, 3 days of doxycycline, and 3 days of azithromycin Secondary Objectives: 1. To perform pharmacokinetic/pharmacodynamics (PK/PD) characterization of the therapeutic responses for doxycycline and azithromycin, incl. serial bacterial load measurements. 2. To define clinical, bacterial, pathophysiological and pharmacological factors associated with disease severity, fever-clearance times (FCT), treatment failures and relapse/re-infection. 3. To determine the minimum inhibitory concentrations (MIC) of clinical Orientia tsutsugamushi isolates to doxycycline, azithromycin and chloramphenicol, using in vitro growth-inhibition assays 4. To genotype all clinical isolates using whole genome sequencing for comparative genomics. 5. To dissect the natural immune response in scrub typhus, using antigen-specific cellular immune and antibody studies, and cytokine profiling
Official title: The Scrub Typhus Antibiotic Resistance Trial (START) Comparing Doxycycline and Azithromycin Treatment Modalities in Areas of Reported Antimicrobial Resistance for Scrub Typhus
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
177
Start Date
2017-10-15
Completion Date
2028-10
Last Updated
2026-04-28
Healthy Volunteers
No
Conditions
Interventions
Doxycycline 7 days
loading dose 200mg PO, then 100mg PO every 12 hours for 7 days
Doxycycline 3 days
loading dose 200mg PO, then 100mg PO every 12 hours for 3 days
Azithromycin 3 days
loading dose 1000mg PO on day 1, then 500mg PO every 24 hours on days 2 and 3
Locations (5)
Shoklo-Malaria Research Unit (SMRU)
Mae Sot, Changwat Tak, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand
Mae Chan District Hospital
Chiang Rai, Thailand
Mae Fah Luang District Hospital
Chiang Rai, Thailand
Mae Suai District Hospital
Chiang Rai, Thailand