Clinical Effectiveness of Tigecycline for Scrub Typhus.

Clinical Efficacy Analysis of Drug Use Tigecycline for Re-creation of Antimicrobial Agents for Treatment of Scrub Typhus.

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:

• [question 1]: Does tigecycline reduce fever faster than doxycycline in scrub typhus?
• [question 2]: Is the use of tigecylcine tolerable in scrub typhus? Participants will assigned as doxycycline or tigecycline groups. Researchers will compare tigecycline group with doxycycline group, using defervescence time and adverse events.

Study Overview

• Status: Completed
• Conditions: Scrub Typhus
• Intervention / Treatment: Drug: doxycycline; Drug: Tigecycline (Tygacil)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Incheon, South Korea, 22332
    • Inha University Hospital
  • Jinju, South Korea, 52727
    • Gyeonsang National University Hospital
  • Chungcheongnam-do
    • Cheonan, Chungcheongnam-do, South Korea, 31116
      • Dankuk university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Doxycycline; Participants receive oral doxycycline	Drug: doxycycline; Doxycycline 100 mg orally every 12 hours for 7 days.
Experimental: Tigecycline; Participants receive intravenous tigecycline	Drug: Tigecycline (Tygacil); Tigecycline 100 mg intravenously as a loading dose, followed by 50 mg intravenously every 12 hours for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	up to 30 days after treatment initiation
adverse events	Occurrence of treatment-emergent adverse events	up to 28 days after treatment initiation

Collaborators and Investigators

• Sponsor: Jin Soo Lee
• Collaborators: Korean Center for Disease Control and Prevention
• Investigators: Principal Investigator: Jin-Soo Lee, MD., PhD., Inha University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: doxycycline; tigecycline; Orientia tsutsugamushi; scrub typhus
• Additional Relevant MeSH Terms: Vector Borne Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Rickettsiaceae Infections; Scrub Typhus; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Naphthacenes; Tetracyclines; Tigecycline; Doxycycline
• Other Study ID Numbers: 2022-04-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No