Scrub TyphusNCT00568711
Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
A study testing doxycycline and rifampin in people with Scrub Typhus, run by Dong-Min Kim at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scrub Typhus
- What is being tested?
- doxycycline and rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chosun University Hospital
Gwangju, Jeollanam-do, 501-717
About this study
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
- Being tested
- doxycycline, rifampin
- Keywords
- Doxycycline,, Rifampin, Scrub typhus.
- Medical subject headings
- Scrub Typhus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycyclineDrug
a 5-day course of 100 mg bid doses of doxycycline
rifampinDrug
a 5-day course of daily 600-mg doses of rifampin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | a 5-day course of daily 200-mg doses of doxycycline Receives: Drug: doxycycline |
| 2 | Active comparator | a 5-day course of daily 600-mg doses of rifampin Receives: Drug: rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point was the fever clearance time
Measured: 4 years
Secondary outcomes (1)
The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse"
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scrub TyphusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-Min Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong-Min Kim, Chosun University Hospital
- Investigators
- Namsoo Cho, Study director, Director of Chosun University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568711
- Sponsor's protocol ID
- IRB043-31
- Other IDs
- IRB043-31
- Status last verified
- Feb 2019
- First submitted
- 5 Dec 2007
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29462266
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus
- ClinicalTrials.gov ID
- NCT00568711
- Acronym / sponsor ID
- IRB043-31
- Conditions
- Scrub Typhus
- Keywords
- Doxycycline,, Rifampin, Scrub typhus.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Dong-Min KimUniversity, hospital or other
- Study start
- Sep 2006 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: doxycyclinea 5-day course of daily 200-mg doses of doxycycline |
| 2 | Active comparator | Drug: rifampina 5-day course of daily 600-mg doses of rifampin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxycyclinea 5-day course of 100 mg bid doses of doxycycline | Drug | 1 |
| rifampina 5-day course of daily 600-mg doses of rifampin | Drug | 2 |
Primary outcome
The primary end point was the fever clearance time
Time frame: 4 years
1 secondary outcome
The secondary end point was evaluated according to the following definitions. "Cure ", "Failure", "Relapse"
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 29462266Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namsoo Cho study director
Director of Chosun University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doxycycline and rifampin in people with Scrub Typhus, run by Dong-Min Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point was the fever clearance time (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00568711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.