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

This study is currently recruiting participants.

Verified by Chosun University Hospital, June 2006

First Received: July 11, 2006 No Changes Posted

Sponsor:	Chosun University Hospital
Information provided by:	Chosun University Hospital
ClinicalTrials.gov Identifier:	NCT00351182

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Antibiotics

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium Telithromycin

U.S. FDA Resources

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

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

Study ID Numbers:	Telit_L_00276
Study First Received:	July 11, 2006
Last Updated:	July 11, 2006
ClinicalTrials.gov Identifier:	NCT00351182 History of Changes
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:

Bacterial Infections
Anti-Infective Agents
Antiprotozoal Agents
Rickettsiaceae Infections
Telithromycin
Pharmacologic Actions
Gram-Negative Bacterial Infections
Anti-Bacterial Agents

Antimalarials
Antiparasitic Agents
Typhus, Epidemic Louse-Borne
Therapeutic Uses
Rickettsia Infections
Scrub Typhus
Doxycycline

ClinicalTrials.gov processed this record on February 08, 2010