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

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.

Study Overview

• Status: Completed
• Conditions: Scrub Typhus
• Intervention / Treatment: Drug: Doxycycline; Drug: Telithromycin

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonnam
    • Gwangju, Jeonnam, Korea, Republic of, 501-717
      • Chosun University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Dong-Min Kim
• Investigators: Study Chair: Dong-Min Kim, Department of Internal Medidine, Chosun University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2005
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: July 11, 2006
• First Submitted That Met QC Criteria: July 11, 2006
• First Posted (Estimate): July 12, 2006

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Doxycycline; Scrub typhus; Telithromycin
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Rickettsia Infections; Rickettsiaceae Infections; Typhus, Epidemic Louse-Borne; Scrub Typhus; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline; Telithromycin
• Other Study ID Numbers: Telit_L_00276