Scrub Typhus
Conditions
Keywords
doxycycline, tigecycline, Orientia tsutsugamushi, scrub typhus
Brief summary
The goal of this randomized case-control study is to analysis of effectiveness of tigecycline in scrub typhus. The main question it aims to answer are: * \[question 1\]: Does tigecycline reduce fever faster than doxycycline in scrub typhus? * \[question 2\]: Is the use of tigecylcine tolerable in scrub typhus? Participants will assigned as doxycycline or tigecycline groups. Researchers will compare tigecycline group with doxycycline group, using defervescence time and adverse events.
Interventions
DRUGdoxycycline
Doxycycline 100 mg orally every 12 hours for 7 days.
Tigecycline 100 mg intravenously as a loading dose, followed by 50 mg intravenously every 12 hours for 5 days.
Sponsors
Jin Soo Lee
Korean Center for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Hospitalization with a fever of 37.5℃ or higher (tympanic temperature measurement standard) and rash or scabs suspected of tsutsugamushi syndrome * If an infectious disease specialist makes a clinical judgment and diagnoses scrub typhus * A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing a detailed explanation of this clinical study and fully understanding it
Exclusion criteria
* Patients with severe complications such as respiratory failure, pneumonia, and encephalitis (researcher determines final exclusion) * Patients with chronic renal dysfunction * Underweight people weighing less than 45Kg * Immunodeficiency: Long-term use of steroids or other immunosuppressive drugs, patients undergoing chemotherapy, etc. (Researcher determines final exclusion) * Pregnant women * Women and men of childbearing potential who are planning to become pregnant during the clinical study period and for 3 months after the end of the clinical study, or who are unwilling to use the following appropriate contraceptive methods\* \* Intrauterine device \[IUD (Intrauterine device), barrier contraception method including spermicide (for female contraceptive vaginal diaphragm/vaginal sponge sponge/cervical cap) and double barrier method (for male use) Excluding simultaneous use of condoms and female condoms), sterilization (vasectomy, vasectomy, tubal ligation, etc.) * If you cannot take the medicine orally * Patients already using other anti-rickettsial drugs (rifampin, chloramphenicol, macrolides, quinolones, tetracyclines) * Patients with shock or multiple organ failure requiring vasopressor/vasoconstrictor, impaired consciousness, respiratory failure requiring mechanical ventilation, and renal dysfunction requiring hemodialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Defervescence | from treatment initiation to defervescence, assessed daily through Day 7 | Time from treatment initiation to defervescence, defined as maintenance of body temperature below 37.3°C for at least 48 consecutive hours without antipyretics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | up to 7 days after treatment initiation | persistence of fever over 3 days after therapy, but no other cause of fever |
| Relapse | up to 30 days after treatment initiation | relapse on 30th days |
| adverse events | up to 28 days after treatment initiation | Occurrence of treatment-emergent adverse events |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJin-Soo Lee, MD., PhD.
Inha University Hospital
Outcome results
None listed