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

Who is this study for? Patients with Scrub Typhus
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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: To perform pharmacokinetic/pharmacodynamics (PK/PD) characterization of the therapeutic responses for doxycycline and azithromycin, incl. serial bacterial load measurements. To define clinical, bacterial, pathophysiological and pharmacological factors associated with disease severity, fever-clearance times (FCT), treatment failures and relapse/re-infection. To determine the minimum inhibitory concentrations (MIC) of clinical Orientia tsutsugamushi isolates to doxycycline, azithromycin and chloramphenicol, using in vitro growth-inhibition assays To genotype all clinical isolates using whole genome sequencing for comparative genomics. To dissect the natural immune response in scrub typhus, using antigen-specific cellular immune and antibody studies, and cytokine profiling

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: No
View:

• Age ≥ 15 years old

• Hospitalization with acute undifferentiated fever (temperature > 37.5°C, tympanic) ≤14 days or patients admitted to hospital with a history of fever ≤ 14 days who subsequently develop fever within 24 hours of admission

• Clinically suspected scrub typhus: defined as acute undifferentiated fever with no clear focus of infection and negative malaria blood smear and/or negative malaria RDT. Patients may have one, none, or a combination of other clinical findings such as eschar, rash, lymphadenopathy, headache, myalgia, cough, nausea and abdominal discomfort.

• A positive scrub typhus RDT (Scrub Typhus IgM RDT, InBios International, Seattle, WA, USA) and/or positive PCR-based detection of O. tsutsugamushi DNA from the admission blood sample

• Written informed consent and/or, written informed assent as required

• Able to take oral medication

Locations
Other Locations
Thailand
Chiangrai Prachanukroh Hospital
Recruiting
Chiang Rai
Shoklo-Malaria Research Unit (SMRU)
Not yet recruiting
Mae Sot
Contact Information
Primary
Assoc. Prof. Daniel Paris
parigi@tropmedres.ac
+6622036373
Backup
Tri Wangrangsimakul
tri@tropmedres.ac
+6622036333
Time Frame
Start Date: October 15, 2017
Estimated Completion Date: October 2024
Participants
Target number of participants: 177
Treatments
Active Comparator: Doxycycline 7 days
loading dose 200mg PO, then 100mg PO every 12 hours for 7 days
Active Comparator: Doxycycline 3 days
loading dose 200mg PO, then 100mg PO every 12 hours for 3 days
Active Comparator: Azithromycin 3 days
loading dose 1000mg PO on day 1, then 500mg PO every 24 hours on days 2 and 3
Authors
Assoc. Prof. Daniel Paris
Related Therapeutic Areas
Sponsors
Collaborators: Chiangrai Prachanukroh Hospital, Shoklo Malaria Research Unit
Leads: University of Oxford

This content was sourced from clinicaltrials.gov

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