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

Condition(s) targeted: Scrub Typhus

Intervention: doxycycline (Drug); rifampin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Chosun University Hospital

Official(s) and/or principal investigator(s):
Namsoo Cho, Study Director, Affiliation: Director of Chosun University Hospital

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

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.

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

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

Primary outcome: The primary end point was the fever clearance time

Secondary outcome: The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse"

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

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

Chosun University Hospital, Gwang-Joo, Jeollanamdo 501-717, Korea, Republic of; Recruiting
Dong-Min Kim, Prof, Phone: 82-62-220-3108, Email: drongkim@chosun.ac.kr

Starting date: September 2006
Ending date: December 2009
Last updated: December 5, 2007