Contact information
Type
Scientific
Primary contact
Dr Paul Newton
ORCID ID
Contact details
Microbiology laboratory
Ministry of Health
Mahosot Hospital
Mahosot Road
Vientiane
-
Laos
+856 (0)21 250752
paul@tropmedres.ac
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
066828
Study information
Scientific title
An open, randomised clinical trial of three days oral doxycycline versus seven days oral doxycycline versus three days oral azithromycin in the treatment of Scrub and Murine Typhus
Acronym
MUT and SUT
Study hypothesis
That fever clearance times and the frequencies of relapse and treatment failure do not differ between three days oral doxycycline versus seven days oral doxycycline versus three days oral azithromycin in the treatment of scrub and murine typhus.
Trial details submitted to the Wellcome Trust 8th June 2005. Please also note that as of 13/02/2007 the anticipated end date of this trial has been extended to 31/12/2008. The inital anticipated end date of this trial was 31/12/2006.
As of 02/02/2009 this record has been extensively updated. All updates can be found under the relevant field with the above update date. Please also note that the anticipated end date has also been extended - the initial anticipated end date was 31/12/2008.
Ethics approval
1. Oxford Tropical Ethics Committee (OXTREC) gave approval on the 27th March 2003 (ref: OXTREC 003-03)
2. Faculty of Medical Sciences, Vientiane, Laos Ethical Committee gave approval on the 3rd June 2003 (ref: FMS 3-6-2003)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Scrub typhus, murine typhus
Intervention
An open, randomised comparative trial of three days oral doxycycline versus seven days oral doxycycline versus three days oral azithromycin.
Added 02/02/2009:
Each of the two diseases have the same three treatment arms:
1. Oral doxycycline 100 mg every 12 hours for 7 days (after a 200 mg loading dose)
2. Doxycycline 100 mg every 12 hours for 3 days (after a 200 mg loading dose)
3. Oral azithromycin 500 mg on day 1 and then 250 mg every 24 hours for 2 more days
Follow up is for one year.
Intervention type
Drug
Phase
Not Applicable
Drug names
Doxycycline, azithromycin
Primary outcome measures
Current information as of 02/02/2009:
Fever clearance time and area under the fever-time curve during inpatient stay.
Initial information at time of registration:
1. Fever clearance times
2. Frequencies of treatment failure
3. Frequencies of relapse
Secondary outcome measures
Added as of 02/02/2009:
1. Treatment failure frequency
2. Relapse frequency
Overall trial start date
04/08/2003
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Current information as of 02/02/2009:
1. Adult (greater than 15 years) non-pregnant patients with suspected typhus. Suspected typhus will be defined as undifferentiated fever (aural temperature greater than 37.5°C), with or without an eschar, with a positive scrub typhus Lateral Flow IgM result or a murine typhus IgM Dip-S-Ticks result
2. Written informed consent to the study
3. Able to stay in hospital for the duration of the treatment (up to 7 days) and high likelihood of completing at least 4 weeks follow up
4. Able to take oral medication
5. A negative urinary pregnancy test for all women of child bearing age
6. None of the exclusion criteria
Initial information at time of registration:
1. Adult (more than or equal to 15 years, either sex) non-pregnant patients with suspected typhus, with a positive scrub typhus Lateral Flow result or a murine typhus Dip-S-Ticks result
2. Written informed consent
3. Able to stay in hospital for the duration of the treatment
4. High likelihood of completing at least four weeks follow up
5. Able to take oral medication
6. A negative urinary pregnancy test for all women of child bearing age
7. None of the exclusion criteria
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
71 patients in each arm for each disease (total: 213 for each disease) (added 02/02/2009)
Participant exclusion criteria
Current information as of 02/02/2009:
1. Known hypersensitivity to tetracycline, doxycycline or azithromycin
2. Administration of chloramphenicol, doxycycline, tetracycline, fluoroquinolones or azithromycin during the preceeding week
3. Pregnancy or breast feeding
4. Contraindications to doxycycline: severe hepatic impairment, known systemic lupus erythematosus (SLE)
5. Contraindications to azithromycin: severe hepatic impairment
6. Severe typhus defined as:
6.1. Reduced level of consciousness
6.2. Clinical jaundice
6.3. Shock (blood pressure [BP] systolic less than 80 mmHg)
6.4. Vomiting sufficient to disallow the use of oral medication
6.5. Clinical or radiological evidence for lung involvement
6.6. Clinical evidence for meningitis/encephalitis or the need for a lumbar puncture (LP)
6.7. Any other syndrome which in the opinion of the admitting doctor constitutes severe typhus (reason must be stated)
Initial information at time of registration:
1. Known hypersensitivity to tetracycline, doxycycline or azithromycin
2. Administration of chloramphenicol, doxycycline, tetracycline, fluoroquinolones or azithromycin during the preceeding week
3. Pregnancy or breast feeding
4. Contraindications to doxycycline or azithromycin and severe typhus
Recruitment start date
04/08/2003
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Laos
Trial participating centre
Microbiology laboratory
Vientiane
-
Laos
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Churchill Hospital
CCVTM
Headington
Oxford
OX3 7LJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 066828)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary