Scrub TyphusNCT07513103
Clinical Effectiveness of Tigecycline for Scrub Typhus.
A study testing doxycycline and Tigecycline (Tygacil) in people with Scrub Typhus, run by Jin Soo Lee at 3 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Scrub Typhus
- What is being tested?
- doxycycline and Tigecycline (Tygacil)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 19 Nov 2022to 5 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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*
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Dankuk university hospital
Cheonan, Chungcheongnam-do, 31116
Inha university hospital
Incheon, 22332
Gyeonsang National University Hospital
Jinju, 52727
About this study
Official title: Clinical Efficacy Analysis of Drug Use Tigecycline for Re-creation of Antimicrobial Agents for Treatment of Scrub Typhus.
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.
- Conditions
- Scrub Typhus
- Being tested
- doxycycline, Tigecycline (Tygacil)
- Keywords
- doxycycline, tigecycline, Orientia tsutsugamushi, scrub typhus
- Medical subject headings
- Scrub Typhus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycyclineDrug
Doxycycline 100 mg orally every 12 hours for 7 days.
Tigecycline (Tygacil)Drug
Tigecycline 100 mg intravenously as a loading dose, followed by 50 mg intravenously every 12 hours for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | Participants receive oral doxycycline Receives: Drug: doxycycline |
| Tigecycline | Experimental | Participants receive intravenous tigecycline Receives: Drug: Tigecycline (Tygacil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from treatment initiation to defervescence, assessed daily through Day 7
Secondary outcomes (3)
Treatment failure
persistence of fever over 3 days after therapy, but no other cause of fever
Measured: up to 7 days after treatment initiation
Relapse
relapse on 30th days
Measured: up to 30 days after treatment initiation
adverse events
Occurrence of treatment-emergent adverse events
Measured: up to 28 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start19 Nov 2022
- Primary completion10 Dec 2024
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scrub TyphusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jin Soo Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Jin Soo Lee, Inha University Hospital
- Investigators
- Jin-Soo Lee, MD., PhD., Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513103
- Sponsor's protocol ID
- 2022-04-017
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Im JH, Jang S, Suh YJ, Lee D, Lee KJ, Kim J, Lee SJ, Baek JH, Park YK, Kim E, Lee SM, Lee HJ, Chung MH, Hong KW, Bae IG, Lee JS. Tigecycline versus doxycycline for scrub typhus: a preliminary randomized trial. Trop Med Health. 2026 Sep 16;54(1):200. doi: 10.1186/s41182-026-01073-8.
PubMed 42750051
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Analysis of Drug Use Tigecycline for Re-creation of Antimicrobial Agents for Treatment of Scrub Typhus.
- ClinicalTrials.gov ID
- NCT07513103
- Acronym / sponsor ID
- 2022-04-017
- Conditions
- Scrub Typhus
- Keywords
- doxycycline, tigecycline, Orientia tsutsugamushi, scrub typhus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Jin Soo LeeUniversity, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention
- Study start
- 19 Nov 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: doxycyclineParticipants receive oral doxycycline |
| Tigecycline | Experimental | Drug: Tigecycline (Tygacil)Participants receive intravenous tigecycline |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxycyclineDoxycycline 100 mg orally every 12 hours for 7 days. | Drug | Doxycycline |
| Tigecycline (Tygacil)Tigecycline 100 mg intravenously as a loading dose, followed by 50 mg intravenously every 12 hours for 5 days. | Drug | Tigecycline |
Primary outcome
Defervescence
Time frame: 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.
3 secondary outcomes
Treatment failure
Time frame: up to 7 days after treatment initiation
Relapse
Time frame: up to 30 days after treatment initiation
adverse events
Time frame: up to 28 days after treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 42750051Im JH, Jang S, Suh YJ, Lee D, Lee KJ, Kim J, Lee SJ, Baek JH, Park YK, Kim E, Lee SM, Lee HJ, Chung MH, Hong KW, Bae IG, Lee JS. Tigecycline versus doxycycline for scrub typhus: a preliminary randomized trial. Trop Med Health. 2026 Sep 16;54(1):200. doi: 10.1186/s41182-026-01073-8.
Related trials for Scrub Typhus
RecruitingPhase 2/3
Rickettsia Clearance Study
Infectious Disease, Therapeutics
Active, not recruitingPhase 4
Scrub Typhus Antibiotic Resistance Trial
Scrub Typhus
Active, not recruitingObservational study
Scrub Typhus Infection Induced Cardiovascular Disease
Scrub Typhus, Cardiovascular Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Soo Lee, MD., PhD. principal investigator
Inha University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doxycycline and Tigecycline (Tygacil) in people with Scrub Typhus, run by Jin Soo Lee at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defervescence (time frame: from treatment initiation to defervescence, assessed daily through Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07513103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.