Clinical Efficacy Analysis of Drug Use Tigecycline for Re-creation of Antimicrobial Agents for Treatment of Scrub Typhus.
| Registry | NCT07513103 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 27 (Actual) |
| Sponsor | Jin Soo Lee (Other); collaborators: Korean Center for Disease Control and Prevention |
| Conditions | Scrub Typhus |
| Interventions | doxycycline, Tigecycline (Tygacil) (Drug) |
| Dates | start 2022-11-19, primary completion 2024-12-10, completion 2025-01-05, first posted 2026-04-06, last updated 2026-08-11 |
| Locations | 3 sites in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Scrub Typhus All trials of doxycycline All trials of Tigecycline (Tygacil)
This multicenter, randomized, open-label clinical trial evaluated the efficacy and tolerability of intravenous tigecycline compared with oral doxycycline in adults hospitalized with scrub typhus. Participants were randomly assigned to receive either intravenous tigecycline or oral doxycycline. The primary efficacy outcome was time to defervescence, and tolerability was assessed based on reported adverse events.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Doxycycline | Active comparator | Drug: doxycycline | Participants receive oral doxycycline |
| Tigecycline | Experimental | Drug: Tigecycline (Tygacil) | Participants receive intravenous tigecycline |
Sex: All, ages: 19 Years to 100 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Dankuk university hospital | Cheonan, Chungcheongnam-do | South Korea | |
| Inha university hospital | Incheon | South Korea | |
| Gyeonsang National University Hospital | Jinju | South Korea |