Condition category
Infections and Infestations
Date applied
07/12/2005
Date assigned
07/12/2005
Last edited
02/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine

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

Publication citations

Additional files

Editorial Notes