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ACTIVE NOT RECRUITING
NCT03083197
PHASE4

Scrub Typhus Antibiotic Resistance Trial

Sponsor: University of Oxford

View on ClinicalTrials.gov

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

DRUG

Doxycycline 7 days

loading dose 200mg PO, then 100mg PO every 12 hours for 7 days

DRUG

Doxycycline 3 days

loading dose 200mg PO, then 100mg PO every 12 hours for 3 days

DRUG

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