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Completed

NCT Number: NCT07513103

Clinical Effectiveness of Tigecycline for 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.

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Key information

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dankuk university hospital, Cheonan, Chungcheongnam-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycycline

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Treatment failure

    Time frame: up to 7 days after treatment initiation

    persistence of fever over 3 days after therapy, but no other cause of fever

  2. Relapse

    Time frame: up to 30 days after treatment initiation

    relapse on 30th days

  3. adverse events

    Time frame: up to 28 days after treatment initiation

    Occurrence of treatment-emergent adverse events

Sponsors and collaborators

Lead sponsor

Jin Soo Lee

Other

Collaborators

  • Korean Center for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 6, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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