Controlled Trial: 5-Day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
Information source: Chosun University Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Scrub Typhus
Intervention: Telithromycin (Drug); Doxycycline (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Chosun University Hospital Official(s) and/or principal investigator(s):
Dong-Min Kim, Study Chair, Affiliation: Department of Internal Medidine, Chosun University Hospital
Overall contact:
Dong-Min Kim, Email: drongkim@chosun.ac.kr
Summary
New antibiotics are required that have antibacterial activity against doxycyline resistant O.
tsutsugamushi, that can be safely used in pregnant women and children, that have a low
possibility of inducing resistance and that do not induce cross resistant to other
antibiotics. Telithromycin has been reported to be effective on Rickettsia, Batonella and
Coxiella burnetii. Therefore, telithromycin may be considered as a substitute antibiotic that
can be used safely in pregnant women and children for rickettsiosis or Orientia infection.
Our study was designed to prove the clinical usefulness of telithromycin by comparing it with
doxycycline for treating mild or moderate scrub typhus.
Clinical Details
Official title: Phase 3 Study of Controlled Trial: 5-Day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy outcome was the fever clearance time; this was defined as the interval between the time at which the first dose of antibiotic was administered and the time at which the oral temperature first fell below 37.3°C and then it remained be
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
We conducted a multicenter prospective study of patients with possible scrub typhus. Adult
patients (aged ≥18 years) who have had fever (temperature: ≥37. 5°C) together with eschar or
a maculopapular skin rash and ≥2 of the following symptoms: headache, malaise, myalgia,
coughing, nausea, and abdominal discomfort, were enrolled after obtaining an informed
consent from the patients or their guardians (10). Each patient was admitted between
September, 2005 to December, 2005 to Chosun University Hospital or one of its two community
branch hospitals (Jangheung Hospital and Chumdan Hospital), which are all located in
southwest Korea.
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 >1 h, a stuporous or comatose level of
consciousness, respiratory failure requiring mechanical ventilation or renal failure
requiring immediate dialysis)
Locations and Contacts
Dong-Min Kim, Email: drongkim@chosun.ac.kr
Chosun University Hospital, Gwang-Ju 501-717, Korea, Republic of; Recruiting
Dong-Min Kim, Email: drongkim@chosun.ac.kr
Dong-Min Kim, Principal Investigator
Additional Information
Starting date: September 2005
Last updated: July 11, 2006
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