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CompletedNCT00568711Updated Feb 8, 2019

Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus

An interventional study of doxycycline and rifampin in Scrub Typhus, sponsored by Dong-Min Kim. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by Dong-Min Kim · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Sep 2006, registered Dec 2007).
Phase
Not applicable
Study type
Interventional
Enrollment
476
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

New antibiotics are required to have not only the antibacterial activity against doxycyline-resistant O. tsutsugamushi but also lower risk for resistance or any cross-resistance to others.

In this prospective, open-label, randomized trial, we enroll patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day rifampin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital, or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.

02

Conditions studied

  • Scrub Typhus

Keywords

  • Doxycycline,
  • Rifampin
  • Scrub typhus.
03

In context

Lead sponsor

Dong-Min Kim is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Inclusion criteria were:

  • Adults aged 18 years or older
  • A fever of higher than 37.5°C
  • The concurrent presence of eschar or a maculopapular skin rash; and the clear presence of more than two symptoms such as headache, malaise, myalgia, coughing, nausea and abdominal discomfort.
  • Patients were hospitalized at Chosun University Hospital in Kwangju, Korea or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.

Exclusion Criteria:

The exclusion criteria were:

  • An inability to take oral medications
  • Pregnancy
  • Hypersensitivity to the trial drugs
  • Previous drug therapy with potential antirickettsial activity (e.g., rifampicin, chloramphenicol, macrolides, fluoroquinolones or tetracyclines) within 48 h prior to admission
  • Severe scrub typhus (shock requiring vasopressor therapy for more than one hour
  • A stuporous or comatose level of consciousness
  • Respiratory failure requiring mechanical ventilation or renal failure requiring immediate dialysis) (4, 10).
  • For the differential diagnosis of scrub typhus from other diseases with similar symptoms (e.g., murine typhus, leptospirosis, hemorrhagic fever with renal syndrome and systemic lupus erythematosus), patients underwent diagnostic tests. We thus excluded patients with concurrent infections who had the risk of causing different outcomes.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
476 participants (actual)

Study arms

  • Active comparator
    1

    a 5-day course of daily 200-mg doses of doxycycline

    Drug: doxycycline

  • Active comparator
    2

    a 5-day course of daily 600-mg doses of rifampin

    Drug: rifampin

Interventions

  • Drugdoxycycline

    a 5-day course of 100 mg bid doses of doxycycline

  • Drugrifampin

    a 5-day course of daily 600-mg doses of rifampin

06

What researchers measure

Primary outcomes

  1. The primary end point was the fever clearance time

    Time frame: 4 years

Secondary outcomes

  1. The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse"

    Time frame: 4 years

07

Study locations

1 site
  • Chosun University Hospital
    Gwangju, Jeollanam-do 501-717, South Korea
08

References and documents

Publications

  • Kim YS, Kim DM, Yoon NR, Jang MS, Kim CM. Effects of Rifampin and Doxycycline Treatments in Patients With Uncomplicated Scrub Typhus: An Open-Label, Randomized, Controlled Trial. Clin Infect Dis. 2018 Aug 1;67(4):600-605. doi: 10.1093/cid/ciy130. PubMed 29462266 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2006 to primary completion in Dec 2009, 39 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2007
First posted
Dec 6, 2007
StartActual
Sep 2006
Primary completionActual
Dec 2009
CompletionActual
Dec 2009
Last update
Feb 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00568711
Lead sponsor
Dong-Min Kim
Responsible party
Dong-Min Kim (Chosun University Hospital, Chosun University Hospital) — Sponsor-investigator
First posted
Dec 6, 2007
Start date
Sep 2006
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Feb 8, 2019

Study contacts

Namsoo Cho
study director · Director of Chosun University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Doxycycline · Rifampin

Other studies in this condition

Scrub Typhus

Other studies from this sponsor

Dong-Min Kim

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