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

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ClinicalTrials.gov Identifier: NCT00568711
Recruitment Status : Unknown
Verified December 2007 by Chosun University Hospital.
Recruitment status was:  Recruiting
First Posted : December 6, 2007
Last Update Posted : December 6, 2007
Sponsor:
Information provided by:
Chosun University Hospital

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.


Condition or disease Intervention/treatment
Scrub Typhus Drug: doxycycline Drug: rifampin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Controlled Trial: 5-Day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
Study Start Date : September 2006
Estimated Study Completion Date : December 2009


Arm Intervention/treatment
Active Comparator: 1
a 5-day course of daily 200-mg doses of doxycycline
Drug: doxycycline
a 5-day course of 100 mg bid doses of doxycycline
Active Comparator: 2
a 5-day course of daily 600-mg doses of rifampin
Drug: rifampin
a 5-day course of daily 600-mg doses of rifampin



Primary Outcome Measures :
  1. The primary end point was the fever clearance time [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse" [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568711


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

Locations
Korea, Republic of
Chosun University Hospital Recruiting
Gwang-Joo, Jeollanamdo, Korea, Republic of, 501-717
Contact: Dong-Min Kim, Prof    82-62-220-3108    drongkim@chosun.ac.kr   
Sponsors and Collaborators
Chosun University Hospital
Investigators
Study Director: Namsoo Cho Director of Chosun University Hospital

Responsible Party: Dong-Min Kim, Department of Internal Medicine, Chosun University College of Medicine
ClinicalTrials.gov Identifier: NCT00568711     History of Changes
Other Study ID Numbers: IRB043-31
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: December 2007

Keywords provided by Chosun University Hospital:
Doxycycline,
Rifampin
Scrub typhus.

Additional relevant MeSH terms:
Typhus, Epidemic Louse-Borne
Scrub Typhus
Rickettsia Infections
Rickettsiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Doxycycline
Rifampin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers