Scrub TyphusNCT03274869
Scrub Typhus Infection Induced Cardiovascular Disease
An observational study of Scrub Typhus and Cardiovascular Complication, run by Eulji University Hospital at 2 sites in South Korea.
Trial summary
Scrub typhus infection has been considered as seasonal and endemic infectious disorder with benign feature. However, the increasing mortality rate of scrub typhus has been recently reported in Southeast Asia and cause of death could be a fetal complicating cardiovascular disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Scrub Typhus, Cardiovascular Complication
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Sep 2022to 30 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Scrub typhus infection without cardiovascular complication Scrub typhus infection with cardiovascular complication
Who may be able to join
- any participants with scrub typhus infection
Who cannot join
- patients under age of 18
- pregnancy
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chung-Buk University Hospital
Chungju, Chung Chung Do, 50122
Chung-Nam University Hospital
Daejeon, Chung Chung Do, 50233
About this study
Official title: Prediction and Early Diagnosis for Cardiovascular Disease Complicated by Scrub Typhus Infection
Scrub typhus infection has been considered as seasonal and endemic infectious disorder with benign feature. However, the increasing mortality rate of scrub typhus has been recently reported in Southeast Asia and cause of death could be a fetal complicating cardiovascular disease. Therefore, the association and predictors for scrub typhus induced cardiovascular disease should be investigated to provide a timely and appropriate diagnosis and to reduce the mortality rate of complicated scrub typhus infection. Therefore, investigators prospectively investigate the association and predictors of cardiovascular disease in the participants with scrub typhus infection.
Read the detailed description
Scrub typhus is a zoonotic disease caused by Orientia tsutsugamushi confined to East Asia including South Korea. It is characterized by fever, headache, rash, and eschar and the majority of patients without complications can recover with an early diagnosis and proper management with antibiotics. However, the increasing mortality rate of scrub typhus has been recently reported in Southeast Asia. Severe complications can be manifested by respiratory distress syndrome, renal failure, hepatic failure, and cardiovascular disease. Especially, cardiovascular complications can lead to cardiogenic shock and sudden cardiac arrest. Therefore, the association and predictors for scrub typhus induced cardiovascular disease should be investigated to provide a timely and appropriate diagnosis and to reduce the mortality rate of complicated scrub typhus infection. Therefore, investigators prospectively investigate the association and predictors of cardiovascular disease in the participants with scrub typhus infection admitted to 3rd referral centers in South Korea.
- Conditions
- Scrub Typhus, Cardiovascular Complication
- Keywords
- Scrub typhus, Cardiovascular Complication
- Medical subject headings
- Scrub Typhus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Scrub typhus without cardiovascular complications | Any participants with the scrub typhus infection without cardiovascular complication will be enrolled as a positive control group during admission and clinically followed by 1 year after discharge | |
| Scrub typhus with cardiovascular complication | Any participants with the scrub typhus infection with cardiovascular complication will be enrolled as a comparison group during admission and clinically followed by 1 year after discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Mortality
Cardiovascular death including sudden cardiac death
Measured: one year
Secondary outcomes (1)
Cardiovascular Complications
Atrial Fibrillation, Acute Heart Failure including acute myocarditis and Ischemic Heart Dease
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Sep 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eulji University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chung-Ang University Hospital, Chungbuk National University Hospital
- Responsible party
- Principal investigator, Ki-Woon Kang, MD, Eulji University Hospital
- Investigators
- Hyu Ryung Cho, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274869
- Sponsor's protocol ID
- EMC 2017-07-006-001
- Status last verified
- Mar 2025
- First submitted
- 3 Sep 2017
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chin JY, Kang KW, Moon KM, Kim J, Choi YJ. Predictors of acute myocarditis in complicated scrub typhus: an endemic province in the Republic of Korea. Korean J Intern Med. 2018 Mar;33(2):323-330. doi: 10.3904/kjim.2016.303. Epub 2017 Feb 23.
PubMed 28226202Jang SY, Kang KW, Kim JH, Kim B, Chin JY, Park SH, Choi YJ, Jung KT, Lee SK. New-onset atrial fibrillation predicting for complicating cardiac adverse outcome in scrub typhus infection. Clin Cardiol. 2019 Dec;42(12):1210-1221. doi: 10.1002/clc.23276. Epub 2019 Oct 3.
PubMed 31580531Kang KW, Hong KW, Lee SK. Identification of novel variants for complicating cardiac disease in the scrub typhus infection using whole genome sequencing. Korean J Intern Med. 2023 Nov;38(6):865-871. doi: 10.3904/kjim.2023.221. Epub 2023 Nov 1.
PubMed 37939667
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Early Diagnosis for Cardiovascular Disease Complicated by Scrub Typhus Infection
- ClinicalTrials.gov ID
- NCT03274869
- Acronym / sponsor ID
- EMC 2017-07-006-001
- Conditions
- Scrub Typhus, Cardiovascular Complication
- Keywords
- Scrub typhus, Cardiovascular Complication
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Eulji University HospitalUniversity, hospital or other
- Collaborators
- Chung-Ang University Hospital, Chungbuk National University Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 7 Sep 2017 (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.
Scrub typhus infection has been considered as seasonal and endemic infectious disorder with benign feature. However, the increasing mortality rate of scrub typhus has been recently reported in Southeast Asia and cause of death could be a fetal complicating cardiovascular disease. Therefore, the association and predictors for scrub typhus induced cardiovascular disease should be investigated to provide a timely and appropriate diagnosis and to reduce the mortality rate of complicated scrub typhus infection. Therefore, investigators prospectively investigate the association and predictors of cardiovascular disease in the participants with scrub typhus infection.
Detailed description
Scrub typhus is a zoonotic disease caused by Orientia tsutsugamushi confined to East Asia including South Korea. It is characterized by fever, headache, rash, and eschar and the majority of patients without complications can recover with an early diagnosis and proper management with antibiotics. However, the increasing mortality rate of scrub typhus has been recently reported in Southeast Asia. Severe complications can be manifested by respiratory distress syndrome, renal failure, hepatic failure, and cardiovascular disease. Especially, cardiovascular complications can lead to cardiogenic shock and sudden cardiac arrest. Therefore, the association and predictors for scrub typhus induced cardiovascular disease should be investigated to provide a timely and appropriate diagnosis and to reduce the mortality rate of complicated scrub typhus infection. Therefore, investigators prospectively investigate the association and predictors of cardiovascular disease in the participants with scrub typhus infection admitted to 3rd referral centers in South Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scrub typhus without cardiovascular complications | – | –Any participants with the scrub typhus infection without cardiovascular complication will be enrolled as a positive control group during admission and clinically followed by 1 year after discharge |
| Scrub typhus with cardiovascular complication | – | –Any participants with the scrub typhus infection with cardiovascular complication will be enrolled as a comparison group during admission and clinically followed by 1 year after discharge |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Scrub typhus infection without cardiovascular complication Scrub typhus infection with cardiovascular complication
Key inclusion criteria (1 listed)
- any participants with scrub typhus infection
Key exclusion criteria (2 listed)
- patients under age of 18
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular Mortality
Time frame: one year
Cardiovascular death including sudden cardiac death
1 secondary outcome
Cardiovascular Complications
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Results publication: PubMed 28226202Chin JY, Kang KW, Moon KM, Kim J, Choi YJ. Predictors of acute myocarditis in complicated scrub typhus: an endemic province in the Republic of Korea. Korean J Intern Med. 2018 Mar;33(2):323-330. doi: 10.3904/kjim.2016.303. Epub 2017 Feb 23.
- Results publication: PubMed 31580531Jang SY, Kang KW, Kim JH, Kim B, Chin JY, Park SH, Choi YJ, Jung KT, Lee SK. New-onset atrial fibrillation predicting for complicating cardiac adverse outcome in scrub typhus infection. Clin Cardiol. 2019 Dec;42(12):1210-1221. doi: 10.1002/clc.23276. Epub 2019 Oct 3.
- Results publication: PubMed 37939667Kang KW, Hong KW, Lee SK. Identification of novel variants for complicating cardiac disease in the scrub typhus infection using whole genome sequencing. Korean J Intern Med. 2023 Nov;38(6):865-871. doi: 10.3904/kjim.2023.221. Epub 2023 Nov 1.
- Individual participant dataSharing planned: Undecided
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
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.
Hyu Ryung Cho principal investigator
Chung-Ang University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scrub Typhus and Cardiovascular Complication, run by Eulji University Hospital at 2 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Cardiovascular Mortality (time frame: one year). 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 NCT03274869, which also lists 3 linked publications.
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 24 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.