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

Not Applicable

Completed

• Conditions: Scrub Typhus
• Interventions: Drug: doxycycline; Drug: rifampin

• Registration Number: NCT00568711
• Lead Sponsor: Dong-Min Kim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	doxycycline	a 5-day course of daily 200-mg doses of doxycycline
2	rifampin	a 5-day course of daily 600-mg doses of rifampin

Primary Outcome Measures

Name	Time	Method
The primary end point was the fever clearance time	4 years

Secondary Outcome Measures

Name	Time	Method
The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse"	4 years

Trial Locations

Locations (1)

Chosun University Hospital; 🇰🇷 Gwangju, Jeonnam, Korea, Republic of