NCT03274869

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2022Aug 2027

First Submitted

Initial submission to the registry

September 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
5 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

September 3, 2017

Last Update Submit

March 20, 2025

Conditions

Scrub TyphusCardiovascular Complication

Keywords

Scrub typhusCardiovascular Complication

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Mortality

    Cardiovascular death including sudden cardiac death

    one year

Secondary Outcomes (1)

  • Cardiovascular Complications

    one year

Study Arms (2)

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

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Scrub typhus infection without cardiovascular complication Scrub typhus infection with cardiovascular complication

You may qualify if:

  • any participants with scrub typhus infection

You may not qualify if:

  • patients under age of 18
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chung-Buk University Hospital

Chungju, Chung Chung Do, 50122, South Korea

Location

Chung-Nam University Hospital

Daejeon, Chung Chung Do, 50233, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 28226202RESULT

  • Jang 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.

    PMID: 31580531RESULT

  • Kang 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.

    PMID: 37939667RESULT

Biospecimen

Retention: SAMPLES WITH DNA

To find novel genotypes of Orientia tsutsugamushi isolated from Scrub typhus infection

MeSH Terms

Conditions

Scrub Typhus

Condition Hierarchy (Ancestors)

Rickettsiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsVector Borne Diseases

Study Officials

  • Hyu Ryung Cho

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2017

First Posted

September 7, 2017

Study Start

September 1, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

August 30, 2027

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations

KR(2)