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

NCT ID: NCT00351182

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2005-12-31

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.

Detailed Description

Randomization and treatment assignment. After submitting a written, informed consent, the patients with an temperature of higher than 37.5°C and who met the eligibility criteria were randomly allocated to receive one of two oral regimens in accordance with a protocol that was determined by the last digit of a resident registration number (the patients with an odd number were treated by a5-daycourseofdaily 200-mg doses of doxycycline,and the patients with an even number were treated by a 5-day course of daily 800-mg doses of telithromycin). Therapy was started immediately after acomprehensive clinical examinationand the collection of specimens for laboratory tests.

Conditions

Scrub Typhus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Telithromycin

Intervention Type: DRUG

Doxycycline

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong-Min Kim

OTHER

Sponsor Role: lead

Responsible Party

Dong-Min Kim

Chosun University Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dong-Min Kim

Role: STUDY_CHAIR

Department of Internal Medidine, Chosun University Hospital

Locations

Chosun University Hospital

Gwangju, Jeollanam-do, South Korea

Countries

South Korea

Other Identifiers

Telit_L_00276

Identifier Type: -

Identifier Source: org_study_id