| Trial name or title |
Scrub Typhus Antibiotic Resistance Trial (START) |
| Methods |
Prospective, open‐label, RCT |
| Participants |
Inclusion criteria
Age ≥ 15 years Hospitalization with acute fever > 37.5°C for ≤ 14 days or admission with a history of fever ≤ 14 days and developing fever within 24 hours after hospitalization Clinically suspected scrub typhus: acute undifferentiated fever with no clear focus of infection (negative malaria blood smear and/or negative malaria RDT). Patients may have 1 or a combination of symptoms and signs such as eschar, rash, lymphadenopathy, headache, myalgia, cough, nausea, and abdominal discomfort. Positive scrub typhus RDT (Scrub Typhus Detect IgM RDT, InBios International, Seattle, Washington, USA) and/or positive PCR‐based detection of Orientia tsutsugamushi DNA from the admission blood sample Written informed consent Ability to take oral medication
Exclusion criteria
Hypersensitivity to trial drugs Administration of anti‐microbial therapy within 7 days before the trial Pregnancy or breast‐feeding Established infection (for example, acute malaria, dengue, leptospirosis, typhoid, Japanese encephalitis) Confirmed TB or TB treatment in ≤ 6 months Severe disease for which the clinical team thinks that current treatment is not enough (for example, IV chloramphenicol and/or PO/NG rifampicin) Long‐term use of immunosuppressants (for example, steroids, chemotherapy, TNF‐inhibitors) and use of HAART for HIV patients Systemic lupus erythematosus and myasthenia gravis
|
| Interventions |
Doxycycline 100 mg PO every 12 hours for 7 days (after loading dose, 200 mg PO) Doxycycline 100 mg PO every 12 hours for 3 days (after loading dose, 200 mg PO) Azithromycin 500 mg PO every 24 hours on days 2 and 3 (after loading dose, 1000 mg PO on day 1) |
| Outcomes |
Primary
Secondary
Resolution of bacteraemia in relation to drug plasma level Occurrence of severe disease or treatment failure/relapse Presence of in vitro anti‐microbial resistance Genotyping of clinical Orientia tsutsugamushi isolates Antigen‐specific positive cellular and humoral immune responses
|
| Starting date |
17 March 2017.
Last update posted: 14 December 2017
Expected completion time: October 2019 |
| Contact information |
Assoc. Prof. Daniel Paris
parigi@tropmedres.ac; Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand |
| Notes |
Location: Shoklo Malaria Research Unit (SMRU), Chiangrai Prachanukroh Hospital, Thailand
Study ID number: START
Source of funding: University of Oxford, Shoklo Malaria Research Unit and Chiangrai Prachanukroh Hospital |
