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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Chosun University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chosun University Hospital
ClinicalTrials.gov Identifier:
NCT00568711
First received: December 5, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 Intervention
Scrub Typhus
Drug: doxycycline
Drug: rifampin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chosun University Hospital:

Primary Outcome Measures:
  • The primary end point was the fever clearance time [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse" [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 476
Study Start Date: September 2006
Estimated Study Completion Date: December 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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, IRB043-31
Study First Received: December 5, 2007
Last Updated: December 5, 2007
Health Authority: Republic of Korea: Chosun University Institutional Ethics Board

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

Additional relevant MeSH terms:
Scrub Typhus
Bacterial Infections
Gram-Negative Bacterial Infections
Rickettsiaceae Infections
Doxycycline
Rifampin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Antitubercular Agents
Enzyme Inhibitors
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014