NCT07513103

Brief 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. The primary efficacy outcome was time to defervescence, and tolerability was assessed based on reported adverse events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2025

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 6, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

2.1 years

First QC Date

August 16, 2023

Last Update Submit

August 9, 2026

Conditions

Scrub Typhus

Keywords

doxycyclinetigecyclineOrientia tsutsugamushiscrub typhus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Treatment failure

    up to 7 days after treatment initiation

  • Relapse

    up to 30 days after treatment initiation

  • adverse events

    up to 28 days after treatment initiation

Study Arms (2)

Doxycycline

ACTIVE COMPARATOR

Participants receive oral doxycycline

Drug: doxycycline

Tigecycline

EXPERIMENTAL

Participants receive intravenous tigecycline

Drug: Tigecycline (Tygacil)

Interventions

doxycyclineDRUG

Doxycycline 100 mg orally every 12 hours for 7 days.

Doxycycline
Tigecycline (Tygacil)DRUG

Tigecycline 100 mg intravenously as a loading dose, followed by 50 mg intravenously every 12 hours for 5 days.

Tigecycline

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with chronic renal dysfunction
  • Underweight people weighing less than 45Kg
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dankuk university hospital

Cheonan, Chungcheongnam-do, 31116, South Korea

Location

Inha university hospital

Incheon, 22332, South Korea

Location

Gyeonsang National University Hospital

Jinju, 52727, South Korea

Location

MeSH Terms

Conditions

Scrub Typhus

Interventions

DoxycyclineTigecycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Jin-Soo Lee, MD., PhD.

    Inha University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2023

First Posted

April 6, 2026

Study Start

November 19, 2022

Primary Completion

December 10, 2024

Study Completion

January 5, 2025

Last Updated

August 11, 2026

Record last verified: 2026-08

Locations

KR(3)