NCT03083197

Scrub Typhus Antibiotic Resistance Trial

The Scrub Typhus Antibiotic Resistance Trial (START) Comparing Doxycycline and Azithromycin Treatment Modalities in Areas of Reported Antimicrobial Resistance for Scrub Typhus

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Detailed description

The funder is USAMRMC - MIDRP and Grant No. DHP-Award D6.7\_15\_C2\_I\_15\_J9\_1317

Conditions

• Scrub Typhus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-10-15
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2017-03-17
• Last updated: 2026-01-12

Locations

2 sites across 1 country: Thailand