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

NCT00568711 | Completed DMC

• 1 other identifier: IRB043-31
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

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.

Conditions

Scrub Typhus

Keywords

Doxycycline,; Rifampin; Scrub typhus.

Outcome Measures

Primary Outcomes (1)

• The primary end point was the fever clearance time

  4 years

Secondary Outcomes (1)

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

  4 years

Study Arms (2)

1

ACTIVE COMPARATOR

a 5-day course of daily 200-mg doses of doxycycline

Drug: doxycycline

2

ACTIVE COMPARATOR

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

Drug: rifampin

Interventions

doxycycline DRUG

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

1

rifampin DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong-Min Kim: lead

Study Sites (1)

Chosun University Hospital

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

Location

Related Publications (1)

• 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.

  PMID: 29462266 DERIVED

MeSH Terms

Conditions

Scrub Typhus

Interventions

Doxycycline; Rifampin

Condition Hierarchy (Ancestors)

Rickettsiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds

Study Officials

• Namsoo Cho

  Director of Chosun University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chosun University Hospital

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: September 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

KR (1)