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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351182
Recruitment Status : Unknown
Verified June 2006 by Chosun University Hospital.
Recruitment status was:  Recruiting
First Posted : July 12, 2006
Last Update Posted : July 12, 2006
Information provided by:
Chosun University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Scrub Typhus Drug: Telithromycin Drug: Doxycycline Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2005

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00351182

Contact: Dong-Min Kim

Korea, Republic of
Chosun University Hospital Recruiting
Gwang-Ju, Korea, Republic of, 501-717
Contact: Dong-Min Kim   
Principal Investigator: Dong-Min Kim         
Sponsors and Collaborators
Chosun University Hospital
Study Chair: Dong-Min Kim Department of Internal Medidine, Chosun University Hospital Identifier: NCT00351182     History of Changes
Other Study ID Numbers: Telit_L_00276
First Posted: July 12, 2006    Key Record Dates
Last Update Posted: July 12, 2006
Last Verified: June 2006

Keywords provided by Chosun University Hospital:
Scrub typhus
5 day Course of Telithromycin versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus

Additional relevant MeSH terms:
Typhus, Epidemic Louse-Borne
Scrub Typhus
Rickettsia Infections
Rickettsiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents