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| Name | Class |
|---|---|
| Korean Center for Disease Control and Prevention | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline | Active Comparator | Participants receive oral doxycycline |
|
| Tigecycline | Experimental | Participants receive intravenous tigecycline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxycycline | Drug | Doxycycline 100 mg orally every 12 hours for 7 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Defervescence | Time from treatment initiation to defervescence, defined as maintenance of body temperature below 37.3°C for at least 48 consecutive hours without antipyretics. | from treatment initiation to defervescence, assessed daily through Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure | persistence of fever over 3 days after therapy, but no other cause of fever | up to 7 days after treatment initiation |
| Relapse | relapse on 30th days |
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Inclusion Criteria:
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](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Soo Lee, MD., PhD. | Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dankuk university hospital | Cheonan | Chungcheongnam-do | 31116 | South Korea | ||
| Inha university hospital |
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| ID | Term |
|---|---|
| D012612 | Scrub Typhus |
| ID | Term |
|---|---|
| D012288 | Rickettsiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Tigecycline (Tygacil) |
| Drug |
Tigecycline 100 mg intravenously as a loading dose, followed by 50 mg intravenously every 12 hours for 5 days. |
|
| up to 30 days after treatment initiation |
| adverse events | Occurrence of treatment-emergent adverse events | up to 28 days after treatment initiation |
| Incheon |
| 22332 |
| South Korea |
| Gyeonsang National University Hospital | Jinju | 52727 | South Korea |
| D007239 | Infections |
| D000079426 | Vector Borne Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |