[Purpose]
◯ Scrub typhus has been on the rise in Korea since 2000. Doxycycline has been used as the first line treatment, but there are limitations especially in the use of severe patients.
◯ Based on actual clinical trials of Tigercycline, an antibacterial drug that was not applied to Tsutsugamushi disease, a new antibacterial drug for Tsutsugamushi disease will be evaluated as a more effective treatment for the treatment of tsutsugamushi disease than doxycycline.

[Contents]
◯ Preparation and performance of clinical trials.   
- Adult patients diagnosed with tsutsugamushi disease were divided into doxycycline and tycycline treatment groups to evaluate treatment responses.
- multicenter, randomized prospective study, The network is organized into three or more general hospitals.
- Target number of people per treatment group: 20 or more (analysis with the aim of securing superiority).
- ①Treatment effects by drug ② Side effects ➂ Evaluation of recurrence.
◯ Finally, the possibility of Tigecycline as a re-creation antibacterial agent for tsutsugamushi disease will be evaluated and suggested.

[Development Results]
◯ Improving the treatment prognosis of scrub typhus patients by evaluating and developing the new treatment effect of tigecycline.
◯ academic conference presentation; 1, Journal publication; 1

[Expected Contribution]
◯ Contributing to the treatment of scrub typhus patients and improving the prognosis of patients. Through this, the economic and social burden is to be reduced. In addition, it intends to contribute to improving national safety through the control of infectious diseases.

Treatment

1. Test Group (Tigecycline)
-  After the first dose of tigecycline 100 mg (Tigacil, Pfizer Korea Pharmaceuticals) intravenously, 50 mg twice daily at 12-hour intervals for 5 days  
- If fever is not relieved even on the 5th day of administration of tigecycline, it is judged as a failure of treatment. And then select an appropriate antibacterial agent among doxycycline, azithromycin, and levofloxacin, and switch to treatment according to the judgment of the investigator.
- After 5 days of treatment, if there are no other medically necessary findings, discharge and proceed with outpatient follow-up

2. Control Group (Doxycycline)
- Doxycycline monohydrate 100mg (Youngpoong Pharmaceutical) 100mg per day for 1 to 7 days, 2 times, orally
- After 7 days of treatment, if there are no other medically necessary findings, discharge and proceed with outpatient follow-up
However, after taking the drug, the patient can be discharged from the hospital under the investigator that clinical recovery is sufficient after 5 days have elapsed by judging whether the symptoms have improved.

Arm Label

Target Number of Participant

Arm Type

Arm Description

-  After the first dose of tigecycline 100 mg (Tigacil, Pfizer Korea Pharmaceuticals) intravenously, 50 mg twice daily at 12-hour intervals for 5 days  
- If fever is not relieved even on the 5th day of administration of tigecycline, it is judged as a failure of treatment. And then select an appropriate antibacterial agent among doxycycline, azithromycin, and levofloxacin, and switch to treatment according to the judgment of the investigator.
- After 5 days of treatment, if there are no other medically necessary findings, discharge and proceed with outpatient follow-up

Arm Label

Target Number of Participant

Arm Type

Arm Description

- Doxycycline monohydrate 100mg (Youngpoong Pharmaceutical) 100mg per day for 1 to 7 days, 2 times, orally
- After 7 days of treatment, if there are no other medically necessary findings, discharge and proceed with outpatient follow-up
However, after taking the drug, the patient can be discharged from the hospital under the investigator that clinical recovery is sufficient after 5 days have elapsed by judging whether the symptoms have improved.

Gender

Age

Description

1. Among inpatients 19 years of age or older who have a fever of 37.5°C or higher (tympanic temperature measurement standard), rash, or crusts suspected of tsutsugamushi, who voluntarily decided to participate in the study   
2. Patient is diagnosed with tsutsugamushi disease by department of infectious disease specialist     
3. After hearing and fully understanding the detailed explanation of this clinical study, a person who voluntarily decides to participate and agrees in writing to abide by the precautions

1. Exclusion complications: Patients with severe complications such as respiratory distress pneumonia, encephalitis (Investigator decides on final exclusion)
2. Chronic renal dysfunction patient
3. Patient with a body weight of <45kg
4. Immunocompromised patients: Administration of glucocorticoid and/or immunoglobulins for long-term
5. Pregnant woman
6. For both male and female patients, the patient and his or her partner of childbearing 
potential who does not agree to use a highly effective or medically acceptable methods of 
contraception during the course of the study and for 3 months following discontinuation of study drug as specified below:
 * IUD (Intrauterinedevice), Barrier contraception that must include spermicide (for women's contraceptive diaphragm/vaginal sponge sponge/cervical cap) and double-blocking method (excluding simultaneous use of male and female condoms) with male condom use, infertility Procedures (vasectomy, vasectomy, tubal ligation, etc.)
7. Unable to take medications by mouth
8. Received any anti-rickettsia drug (including rifampin, chloramphenicol, macrolide, quinolone and tetracycline)
9. Patients with shock or multiple organ failure that require vasopressors/vasoconstrictors, patients with reduced consciousness, patients with respiratory failure that require mechanical ventilation, patients with renal failure requiring hemodialysis
10. Diagnosed with a disease other than tsutsugamushi

Time from antibiotic administration to 37.3°C or lower and maintained for more than 48 hours without fever-reducing drugs

Time from antibiotic administration to 37.3°C or lower and maintained for more than 48 hours without fever-reducing drugs

(1) To assess the antipyretic on the third day of treatment (treatment success / failure) (2) Whether or not Tsutsugamushi disease recurs after 4 weeks (second outpatient visit) from participating in the study

(1) To assess the antipyretic on the third day of treatment (treatment success / failure) (2) Whether or not Tsutsugamushi disease recurs after 4 weeks (second outpatient visit) from participating in the study