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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Scrub Typhus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

a 5-day course of daily 200-mg doses of doxycycline

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

a 5-day course of 100 mg bid doses of doxycycline

2

a 5-day course of daily 600-mg doses of rifampin

Group Type ACTIVE_COMPARATOR

rifampin

Intervention Type DRUG

a 5-day course of daily 600-mg doses of rifampin

Interventions

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doxycycline

a 5-day course of 100 mg bid doses of doxycycline

Intervention Type DRUG

rifampin

a 5-day course of daily 600-mg doses of rifampin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No