Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
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

2026-10

Last Updated

2026-01-12

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 (2)

Shoklo-Malaria Research Unit (SMRU)

Mae Sot, Changwat Tak, Thailand

Chiangrai Prachanukroh Hospital

Chiang Rai, Thailand