Oral doxycycline versus oral azithromycin in the treatment of Scrub and Murine Typhus in Laos
| ISRCTN | ISRCTN47812566 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47812566 |
| Secondary identifying numbers | 066828, 106698/Z/14/Z |
- Submission date
- 07/12/2005
- Registration date
- 07/12/2005
- Last edited
- 23/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul Newton
Scientific
Scientific
Microbiology laboratory
Ministry of Health
Mahosot Hospital
Mahosot Road
Vientiane
-
Lao People's Democratic Republic
| Phone | +856 (0)21 250752 |
|---|---|
| paul@tropmedres.ac |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | MUT and SUT |
| Study objectives | 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. |
| Ethics approval(s) | 1. Oxford Tropical Ethics Committee (OXTREC), 27/03/2003, ref: OXTREC 003-03 2. Faculty of Medical Sciences, Vientiane, Laos Ethical Committee, 03/06/2003, ref: FMS 3-6-2003 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Doxycycline, azithromycin |
| Primary outcome measure | 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 study start date | 04/08/2003 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 71 patients in each arm for each disease (total: 213 for each disease) (added 02/02/2009) |
| Key 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 childbearing age 7. None of the exclusion criteria |
| Key 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 breastfeeding 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 |
| Date of first enrolment | 04/08/2003 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Lao People's Democratic Republic
Study participating centre
Mahosot Hospital
Vientiane
-
Lao People's Democratic Republic
-
Lao People's Democratic Republic
Sponsor information
University of Oxford (UK)
University/education
University/education
Churchill Hospital
CCVTM
Headington
Oxford
OX3 7LJ
England
United Kingdom
| Website | http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Wellcome Trust (grant ref: 066828)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/02/2019 | Yes | No |
Editorial Notes
23/09/2020: Internal review.
19/07/2018: Publication reference added.
02/02/2009: This record was extensively updated, all updates can be found under the relevant field with the above update date. Please also note that the overall trial end date was changed from 31/12/2008 to 31/12/2009.
13/02/2007: The overall trial end date was changed from 31/12/2006 to 31/12/2008.
08/06/2005: Trial details submitted to the Wellcome Trust.
