Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
177 participants
INTERVENTIONAL
2017-10-15
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Controlled Trial: 5-day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
NCT00351182
Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
NCT00568711
Rickettsia Clearance Study
NCT05972772
Eschar Investigations in Scrub Typhus
NCT02915861
Efficacy of Azithromycin Plus Doxycycline Versus Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever
NCT05398055
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Doxycycline 7 days
loading dose 200mg PO, then 100mg PO every 12 hours for 7 days
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
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
Azithromycin 3 days
loading dose 1000mg PO on day 1, then 500mg PO every 24 hours on days 2 and 3
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Administration of doxycycline, azithromycin, chloramphenicol, rifampicin, or tetracycline during the preceding 7 days
* Pregnancy or breast-feeding
* Patients with myasthenia gravis or systemic lupus erythematosus
* Patients with an established infection (diagnostic test required) e.g. acute malaria, dengue, leptospirosis, typhoid, Japanese encephalitis etc.
* Current TB or TB treatment in ≤ 6 months (contain active antibiotics against Orientia spp.)
* Current HAART use for HIV, long term use of immunosuppressants (e.g. steroids, chemotherapy, TNF-inhibitors and related agents)
* Patients with severe disease whom the clinical team feel their condition necessitates the need for additional scrub typhus treatment beyond the allocated antibiotic treatment assigned at randomization (e.g. IV chloramphenicol and/or PO/NG rifampicin)
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shoklo Malaria Research Unit
OTHER
Chiangrai Prachanukroh Hospital
OTHER
University of Oxford
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Assoc. Prof. Daniel Paris
Role: PRINCIPAL_INVESTIGATOR
Mahidol-Oxford Tropical Medicine Research Unit, Bangkok, Thailand
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shoklo-Malaria Research Unit (SMRU)
Mae Sot, Changwat Tak, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
START
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.