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

This study is currently recruiting participants.

Verified by Chosun University Hospital, December 2007

First Received: December 5, 2007 No Changes Posted

Sponsor:	Chosun University Hospital
Information provided by:	Chosun University Hospital
ClinicalTrials.gov Identifier:	NCT00568711

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Antibiotics

Drug Information available for: Rifampin Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

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
1: Active Comparator a 5-day course of daily 200-mg doses of doxycycline	Drug: doxycycline a 5-day course of 100 mg bid doses of doxycycline
2: Active Comparator 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

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, Jeollanamdo
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:	Department of Internal Medicine, Chosun University College of Medicine ( Dong-Min Kim )
Study ID Numbers:	IRB043-31, IRB043-31
Study First Received:	December 5, 2007
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00568711 History of Changes
Health Authority:	Republic of Korea: Chosun University Institutional Ethics Board

Keywords provided by Chosun University Hospital:

Doxycycline,
Rifampin
Scrub typhus.

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Rickettsiaceae Infections
Pharmacologic Actions
Antibiotics, Antitubercular
Gram-Negative Bacterial Infections
Rifampin
Anti-Bacterial Agents

Antimalarials
Antiparasitic Agents
Typhus, Epidemic Louse-Borne
Therapeutic Uses
Rickettsia Infections
Antitubercular Agents
Scrub Typhus
Nucleic Acid Synthesis Inhibitors
Doxycycline
Leprostatic Agents

ClinicalTrials.gov processed this record on November 25, 2009