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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Chosun University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chosun University Hospital
ClinicalTrials.gov Identifier:
NCT00351182
First received: July 11, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted

July 11, 2006
July 11, 2006
September 2005
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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
Same as current
No Changes Posted
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Controlled Trial: 5-Day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
Phase 3 Study of Controlled Trial: 5-Day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Scrub Typhus
  • Drug: Telithromycin
  • Drug: Doxycycline
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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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)
Both
18 Years and older
No
Contact: Dong-Min Kim drongkim@chosun.ac.kr
Korea, Republic of
 
NCT00351182
Telit_L_00276
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Chosun University Hospital
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Study Chair: Dong-Min Kim Department of Internal Medidine, Chosun University Hospital
Chosun University Hospital
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP