Clinical Trials Directory

Trials / Completed

CompletedNCT00351182

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

Phase 3 Study of Controlled Trial: 5-day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
92 (actual)
Sponsor
Dong-Min Kim · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGTelithromycin
DRUGDoxycycline

Timeline

Start date
2005-09-01
Primary completion
2005-12-01
Completion
2005-12-01
First posted
2006-07-12
Last updated
2019-02-08

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT00351182. Inclusion in this directory is not an endorsement.