Official Title: “Controlled Trial: 5-Day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus”

New antibiotics are required to have not only the antibacterial activity against doxycyline-resistant O. tsutsugamushi but also lower risk for resistance or any cross-resistance to others.

In this prospective, open-label, randomized trial, we enroll patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day rifampin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital, or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: doxycycline
  • a 5-day course of 100 mg bid doses of doxycycline
• Drug: rifampin
  • a 5-day course of daily 600-mg doses of rifampin

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • a 5-day course of daily 200-mg doses of doxycycline
• Active Comparator: 2
  • a 5-day course of daily 600-mg doses of rifampin

Primary Measures

• The primary end point was the fever clearance time
  • Time Frame: 4 years
    Safety Issue?: Yes

Secondary Measures

• The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse"
  • Time Frame: 4 years
    Safety Issue?: Yes

Inclusion Criteria:

Inclusion criteria were:

• Adults aged 18 years or older
• A fever of higher than 37.5°C
• The concurrent presence of eschar or a maculopapular skin rash; and the clear presence of more than two symptoms such as headache, malaise, myalgia, coughing, nausea and abdominal discomfort.
• Patients were hospitalized at Chosun University Hospital in Kwangju, Korea or one of its two community-based affiliated hospitals which are all located in southwestern
• Korea between 2006 and 2009.

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 more than one hour
• A stuporous or comatose level of consciousness
• Respiratory failure requiring mechanical ventilation or renal failure requiring immediate dialysis) (4, 10).
• For the differential diagnosis of scrub typhus from other diseases with similar symptoms (e.g., murine typhus, leptospirosis, hemorrhagic fever with renal syndrome and systemic lupus erythematosus), patients underwent diagnostic tests. We thus excluded patients with concurrent infections who had the risk of causing different outcomes.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chosun University Hospital

Overall Clinical Trial Officials and Contacts

Namsoo Cho Study Director Director of Chosun University Hospital  

Overall Contact: Dong-Min Kim, Prof 82-62-220-3108 drongkim@chosun.ac.kr

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568711

Study ID Number: IRB043-31

ClinicalTrials.gov Identifier: NCT00568711

Health Authority: Republic of Korea: Chosun University Institutional Ethics Board