Clinical trial NCT00568711: Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
Official title: Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scrub Typhus
Keywords: Doxycycline,
Rifampin
Scrub typhus.
Lead sponsor: Chosun University Hospital
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary end point was the fever clearance time
timeFrame: 4 years
Secondary outcomes:
measure: The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse"
timeFrame: 4 years
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
state: Jeonnam
Study officials:
affiliation: Director of Chosun University Hospital
name: Namsoo Cho
role: STUDY_DIRECTOR
References:
citation: Kim YS, Kim DM, Yoon NR, Jang MS, Kim CM. Effects of Rifampin and Doxycycline Treatments in Patients With Uncomplicated Scrub Typhus: An Open-Label, Randomized, Controlled Trial. Clin Infect Dis. 2018 Aug 1;67(4):600-605. doi: 10.1093/cid/ciy130.