Melioidosis ERadication THerapy/THailand
| ISRCTN | ISRCTN86140460 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86140460 |
| Secondary identifying numbers | 077166 |
- Submission date
- 23/11/2005
- Registration date
- 23/11/2005
- Last edited
- 19/06/2015
- 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 Ploenchan Chetchotsakd
Scientific
Scientific
Khon Kaen University
Department of Medicine
Faculty of Medicine
Srinagarind Hospital
Mitrapharp Highways
Khon Kaen
40002
Thailand
| Phone | +66 (0)4 3363168 |
|---|---|
| ploencha@kku.ac.th |
Study information
| Study design | Placebo-controlled randomised multicentre study |
|---|---|
| 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 below to request a patient information sheet |
| Scientific title | A comparison of doxycycline plus trimethoprim-sulphamethoxazole versus trimethoprim-sulphamethoxazole as maintenance therapy for melioidosis |
| Study acronym | MERTH |
| Study objectives | To evaluate the efficacy, effectiveness and compliance of Trimethoprim-Sulphamethoxazole (TMP-SMX) compared with doxycycline, Trimethoprim (TMP), and Sulphamethoxazole (SMX) in the oral maintenance phase treatment of melioidosis. |
| Ethics approval(s) | 1. The Ethical Review Committee for Research in Human Subjects, Ministry of Public Health, Thailand (IRB00001629), 27/07/2005, ref: 67/2548 2. The Khon Kaen University Ethics Committee (IRB00001189), 20/05/2005, ref: HE7471005 3. The Oxford Tropical Research Ethics Committee (OXTREC), 04/11/2005, ref: 021-05 |
| Health condition(s) or problem(s) studied | Melioidosis |
| Intervention | The patients will be randomised into two groups, and the randomisation will be performed in advance by blocks of ten. Pre-prepared treatment-containing packs will be labelled with the consecutive study numbers. The study drugs include either of the combinations below: 1. Three drugs: a. Co-trimoxazole (10 mg TMP and 50 mg SMX/kg/day): three adult tablets (80 mg TMP/tab), twice daily. The dose of co-trimoxazole will be reduced to two tablets, twice daily in case of patients with creatinine clearance less than 30 ml/min or who weigh less than 35 kg, and increased to four tablets, twice daily in case of patients who weigh more than 65 kg. b. Doxycycline (4 mg/kg/day): one tablet twice daily. 2. Two drugs: a. Co-trimoxazole (10 mg TMP and 50 mg SMX/kg/day): three adult tablets (80 mg TMP/tab), twice daily. The dose of co-trimoxazole will be reduced to two tablets, twice daily in case of patients with creatinine clearance less than 30 ml/min or who weigh less than 35 kg, and increased to four tablets, twice daily in case of patients who weigh more than 65 kg. b. Placebo (identical tablet as doxycycline): one tablet twice daily. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Co-trimoxazole (Trimethoprim and sulphamethoxazole), doxycycline |
| Primary outcome measure | 1. Mortality 2. Recurrent disease: this is defined as clinical features of melioidosis after initial improvement, in association with cultures from any site positive for Burkholderia pseudomallei. This can be any time point during or after stopping antibiotic treatment. |
| Secondary outcome measures | 1. Clinical recurrence: recurrent clinical features of melioidosis treated as such but not confirmed by positive culture 2. Treatment failure: clinical decision to change treatment according to inadequate response to therapy 3. Adverse drug reactions, including drug allergy 4. Drug compliance: based on interview and pill counting |
| Overall study start date | 26/10/2005 |
| Completion date | 31/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Culture-confirmed melioidosis 2. Satisfactory completion of intravenous therapy and able to take oral medication 3. Patients with mild localised disease who are not considered to require intravenous treatment by their primary physician are eligible if they agree to return for follow up 5. Aged over 14 years, either sex 6. High likelihood of completing at least six months follow up 7. Willingness to participate in the study and written, informed consent obtained from the patient |
| Key exclusion criteria | 1. Pregnancy or breast feeding 2. Contraindications to doxycycline: severe hepatic impairment (aspartate aminotransferase [AST], alanine aminotransferase [ALT] more than or equal to five times of upper limit of normal) 3. Contraindications to TMP-SMX: Glucose-6-phosphate dehydrogenase (G6PD) deficiency, renal impairment (creatinine clearance less than 15 ml/min) 4. History of hypersensitivity to doxycycline, TMP or SMX 5. Infecting isolate is resistant to TMP-SMX by E-test 6. Relapse melioidosis with disease free interval of less than two years |
| Date of first enrolment | 26/10/2005 |
| Date of final enrolment | 31/10/2008 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Khon Kaen University
Khon Kaen
40002
Thailand
40002
Thailand
Sponsor information
Khon Kaen University (Thailand)
University/education
University/education
Department of Medicine
Faculty of Medicine
Srinagarind Hospital
Mitrapharp Highways
Khon Kaen
40002
Thailand
| Website | http://www.kku.ac.th/eng/index.html |
|---|---|
"ROR" |
https://ror.org/03cq4gr50 |
Funders
Funder type
Charity
Wellcome Trust (UK) (grant ref: 077166)
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 | 01/03/2014 | Yes | No |
