Controlled Trial: 5-Day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
Recruitment status was Recruiting
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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 |
- 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 |
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| Contact: Dong-Min Kim | drongkim@chosun.ac.kr |
| 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 | |
| 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:
|
Typhus, Epidemic Louse-Borne Scrub Typhus Rickettsiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Rickettsia Infections Doxycycline Doxycycline hyclate |
Telithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 23, 2013