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Completed

NCT Number: NCT00568711

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chosun University Hospital

Gwangju, Jeollanam-do, 501-717, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxycycline

Drug

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

Rifampin

Drug

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

Primary outcomes

  1. The primary end point was the fever clearance time

    Time frame: 4 years

Secondary outcomes

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

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Dong-Min Kim

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 6, 2007
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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