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
  Purpose

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 Intervention Phase
Scrub Typhus
Drug: Telithromycin
Drug: Doxycycline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chosun University Hospital:

Primary Outcome Measures:
  • 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

Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351182

Contacts
Contact: Dong-Min Kim drongkim@chosun.ac.kr

Locations
Korea, Republic of
Chosun University Hospital Recruiting
Gwang-Ju, Korea, Republic of, 501-717
Contact: Dong-Min Kim       drongkim@chosun.ac.kr   
Principal Investigator: Dong-Min Kim         
Sponsors and Collaborators
Chosun University Hospital
Investigators
Study Chair: Dong-Min Kim Department of Internal Medidine, Chosun University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00351182     History of Changes
Other Study ID Numbers: Telit_L_00276
Study First Received: July 11, 2006
Last Updated: July 11, 2006
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Scrub Typhus
Typhus, Epidemic Louse-Borne
Rickettsiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Rickettsia Infections
Doxycycline
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 18, 2014