MelioidosisPREMELNCT02089152
A Single-blind Stepped Wedge Cluster Randomized Controlled Behaviour Change Trial to Determine Effectiveness of Prevention Programme of Melioidosis in Diabetics in Ubon Ratchathani, Northeast Thailand
A study testing An educational programme for prevention of melioidosis in people with Melioidosis, run by University of Oxford at 1 site in Thailand.
Trial summary
Study hypothesis: Prevention programme for melioidosis can reduce incidences of overall hospitalization due to infectious diseases and due to culture-confirmed melioidosis in diabetic population in northeast Thailand This study is a prospective single-blind multicentre stepped wedge cluster randomized controlled… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Melioidosis
- What is being tested?
- An educational programme for prevention of melioidosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,075 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2014to 31 Dec 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (Include pregnant women) , aged from 18 to 65 years old
- Diagnosed of diabetes according to American Diabetes Association 2013 as following
- Fasting plasma glucose (FPG) ≥ 126 mg/dl or
- HbA1C ≥ 6.5% or
- 2 hour plasma glucose (PG) ≥ 200 mg/dl during an OGTT or
- Classic symptoms of hyperglycaemia with a random PG ≥ 200 mg/dl
- Oriented and conversed normally
- Willingness to participate in the study, and written, informed consent obtained from patient
Who cannot join
- Confused or unable to communicate
- Diagnosed of melioidosis and has not completed oral-eradicative treatment for melioidosis
Trial locations and contacts
1 site in 1 country.
About this study
Study hypothesis:
Prevention programme for melioidosis can reduce incidences of overall hospitalization due to infectious diseases and due to culture-confirmed melioidosis in diabetic population in northeast Thailand
This study is a prospective single-blind multicentre stepped wedge cluster randomized controlled behaviour change trial in 9,000 diabetics in Ubon Ratchathani, northeast Thailand.
Read the detailed description
Melioidosis is an infectious disease caused by soil-dwelling Gram-negative bacilli Burkholderia pseudomallei. The disease is highly endemic in northeast Thailand. Diabetes mellitus is the major underlying risk factor for melioidosis, occurring in more than 50% of all culture-proven melioidosis patients. The annual incidence of melioidosis in diabetes in northeast Thailand is currently 244 per 100,000, and the overall case fatality rate is about 40%. The number of people dying from melioidosis is now comparable to deaths from tuberculosis, and exceeds those from malaria, diarrheal illnesses and measles combined. Melioidosis is potentially preventable since infection occurs as a direct result of exposure to B. pseudomallei in the environment. Nonetheless, most of Thai people have never heard of melioidosis, there is currently no vaccine for melioidosis, and formal prevention guideline are lacking worldwide.
The investigators recently developed new guidelines for the prevention of melioidosis in Thailand; including avoidance of direct contact with soil or environmental water and use of protective gear if contact is necessary, consumption of bottled or boiled water only, and avoidance of direct contact with heavy rain and dust clouds.
The investigators aim to conduct a clinical trial to determine effectiveness of the proposed prevention programme of melioidosis. The investigators also predict that the prevention programme of melioidosis will also prevent other common infectious diseases with have similar routes of infection, such as leptospirosis and acute diarrhea. The outcome of the RCT will be crucial evidence for the Ministry of Public Health (MoPH) Thailand for their consideration of policy changes for the prevention of melioidosis countrywide.
The funder: Wellcome Trust. Grant reference number: 101103/Z/13/Z
Result:
Pubmed link: https://pubmed.ncbi.nlm.nih.gov/34170931/
PLoS NTD link: https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0009060
DOI: https://doi.org/10.1371/journal.pntd.0009060
MedRxiv: https://www.medrxiv.org/content/10.1101/2020.12.18.20248448v1
- Conditions
- Melioidosis
- Being tested
- An educational programme for prevention of melioidosis
- Keywords
- Diabetes, Melioidosis, stepped wedge trial, behaviour change, Education program
- Medical subject headings
- Melioidosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An educational programme for prevention of melioidosisOther
The intervention will be randomly implemented at 10, 10 and 10 diabetic clinics at the end of years 1, 2 and 3, respectively. The education will be conducted using small group education, in which 20 to 25 participants at a time will attend group sessions conducted by the study team.
| Study group | Role | What they receive |
|---|---|---|
| Cluster A | Other | General education for prevention of diabetic complications in year 1, Melioidosis prevention education in years 2, 3 and 4. Receives: Other: An educational programme for prevention of melioidosis |
| Cluster B | Other | General education for prevention of diabetic complications in year 1 and 2, Melioidosis prevention education in year 3 and 4. Receives: Other: An educational programme for prevention of melioidosis |
| Cluster C | Other | General education for prevention of diabetic complications in year 1, 2 and 3, Melioidosis prevention education in year 4. Receives: Other: An educational programme for prevention of melioidosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall hospital admissions due to infectious diseases
Infectious diseases will be determined by International Classification of Disease 10 (ICD10) defined by attending physicians.
Measured: Up to 4 years
Culture-confirmed melioidosis
Culture-confirmed melioidosis is defined as presentation with clinical features of melioidosis in association with cultures from any clinical specimen positive for Burkholderia pseudomallei.
Measured: Up to 4 years
Secondary outcomes (2)
Overall mortality
Overall mortality is defined as death from all causes.
Measured: Up to 4 years
Overall melioidosis
Overall melioidosis is defined as a combination of culture confirmed melioidosis and clinical melioidosis. Clinical melioidosis is defined as presentation with clinical features of melioidosis in association with cultures from all clinical specimens negative for Burkholderia pseudomallei.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study start1 Apr 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for MelioidosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9,075 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Assist Prof. Direk Limmathurotsakul, M.D., Principal investigator, Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089152
- Sponsor's protocol ID
- MICRO1307
- Acronym
- PREMEL
- Status last verified
- Sep 2019
- First submitted
- 13 Mar 2014
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Limmathurotsakul D, Wongratanacheewin S, Teerawattanasook N, Wongsuvan G, Chaisuksant S, Chetchotisakd P, Chaowagul W, Day NP, Peacock SJ. Increasing incidence of human melioidosis in Northeast Thailand. Am J Trop Med Hyg. 2010 Jun;82(6):1113-7. doi: 10.4269/ajtmh.2010.10-0038.
PubMed 20519609Limmathurotsakul D, Peacock SJ. Melioidosis: a clinical overview. Br Med Bull. 2011;99:125-39. doi: 10.1093/bmb/ldr007. Epub 2011 May 9.
PubMed 21558159Currie BJ, Dance DA, Cheng AC. The global distribution of Burkholderia pseudomallei and melioidosis: an update. Trans R Soc Trop Med Hyg. 2008 Dec;102 Suppl 1:S1-4. doi: 10.1016/S0035-9203(08)70002-6.
PubMed 19121666Limmathurotsakul D, Dance DA, Wuthiekanun V, Kaestli M, Mayo M, Warner J, Wagner DM, Tuanyok A, Wertheim H, Yoke Cheng T, Mukhopadhyay C, Puthucheary S, Day NP, Steinmetz I, Currie BJ, Peacock SJ. Systematic review and consensus guidelines for environmental sampling of Burkholderia pseudomallei. PLoS Negl Trop Dis. 2013;7(3):e2105. doi: 10.1371/journal.pntd.0002105. Epub 2013 Mar 21.
PubMed 23556010Suputtamongkol Y, Hall AJ, Dance DA, Chaowagul W, Rajchanuvong A, Smith MD, White NJ. The epidemiology of melioidosis in Ubon Ratchatani, northeast Thailand. Int J Epidemiol. 1994 Oct;23(5):1082-90. doi: 10.1093/ije/23.5.1082.
PubMed 7860160Faa AG, Holt PJ. Melioidosis in the Torres Strait islands of far North Queensland. Commun Dis Intell Q Rep. 2002;26(2):279-83. doi: 10.33321/cdi.2002.26.26.
PubMed 12206383Limmathurotsakul D, Kanoksil M, Wuthiekanun V, Kitphati R, deStavola B, Day NP, Peacock SJ. Activities of daily living associated with acquisition of melioidosis in northeast Thailand: a matched case-control study. PLoS Negl Trop Dis. 2013;7(2):e2072. doi: 10.1371/journal.pntd.0002072. Epub 2013 Feb 21.
PubMed 23437412Limmathurotsakul D, Wongsuvan G, Aanensen D, Ngamwilai S, Saiprom N, Rongkard P, Thaipadungpanit J, Kanoksil M, Chantratita N, Day NP, Peacock SJ. Melioidosis caused by Burkholderia pseudomallei in drinking water, Thailand, 2012. Emerg Infect Dis. 2014 Feb;20(2):265-8. doi: 10.3201/eid2002.121891.
PubMed 24447771Wongsuvan N, Malasit M, Hongsuwan M, et al. Defining beliefs and environmental contraints on prevention of melioidosis in northeast Thailand. 2013. (manuscript under preparation)
Limmathurosakul D, Lubell Y, Day N, Peacock N. Modelling the cost-effectiveness of strategies to prevent melioidosis in northeast Thailand. 2013. (manuscript under preparation)
Chaowagul W, White NJ, Dance DA, Wattanagoon Y, Naigowit P, Davis TM, Looareesuwan S, Pitakwatchara N. Melioidosis: a major cause of community-acquired septicemia in northeastern Thailand. J Infect Dis. 1989 May;159(5):890-9. doi: 10.1093/infdis/159.5.890.
PubMed 2708842Leelarasamee A, Bovornkitti S. Melioidosis: review and update. Rev Infect Dis. 1989 May-Jun;11(3):413-25. doi: 10.1093/clinids/11.3.413.
PubMed 2665001Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
PubMed 23512568Cheng AC, Currie BJ, Dance DAB, Funnell SGP, Limmathurotsakul D, Simpson AJH, Peacock SJ. Clinical definitions of melioidosis. Am J Trop Med Hyg. 2013 Mar;88(3):411-413. doi: 10.4269/ajtmh.12-0555.
PubMed 23468355Moulton LH, Golub JE, Durovni B, Cavalcante SC, Pacheco AG, Saraceni V, King B, Chaisson RE. Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention. Clin Trials. 2007;4(2):190-9. doi: 10.1177/1740774507076937.
PubMed 17456522
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind Stepped Wedge Cluster Randomized Controlled Behaviour Change Trial to Determine Effectiveness of Prevention Programme of Melioidosis in Diabetics in Ubon Ratchathani, Northeast Thailand
- ClinicalTrials.gov ID
- NCT02089152
- Acronym / sponsor ID
- PREMEL / MICRO1307
- Conditions
- Melioidosis
- Keywords
- Diabetes, Melioidosis, stepped wedge trial, behaviour change, Education program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,075 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Mar 2014 (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.
Study hypothesis:
Prevention programme for melioidosis can reduce incidences of overall hospitalization due to infectious diseases and due to culture-confirmed melioidosis in diabetic population in northeast Thailand
This study is a prospective single-blind multicentre stepped wedge cluster randomized controlled behaviour change trial in 9,000 diabetics in Ubon Ratchathani, northeast Thailand.
Detailed description
Melioidosis is an infectious disease caused by soil-dwelling Gram-negative bacilli Burkholderia pseudomallei. The disease is highly endemic in northeast Thailand. Diabetes mellitus is the major underlying risk factor for melioidosis, occurring in more than 50% of all culture-proven melioidosis patients. The annual incidence of melioidosis in diabetes in northeast Thailand is currently 244 per 100,000, and the overall case fatality rate is about 40%. The number of people dying from melioidosis is now comparable to deaths from tuberculosis, and exceeds those from malaria, diarrheal illnesses and measles combined. Melioidosis is potentially preventable since infection occurs as a direct result of exposure to B. pseudomallei in the environment. Nonetheless, most of Thai people have never heard of melioidosis, there is currently no vaccine for melioidosis, and formal prevention guideline are lacking worldwide.
The investigators recently developed new guidelines for the prevention of melioidosis in Thailand; including avoidance of direct contact with soil or environmental water and use of protective gear if contact is necessary, consumption of bottled or boiled water only, and avoidance of direct contact with heavy rain and dust clouds.
The investigators aim to conduct a clinical trial to determine effectiveness of the proposed prevention programme of melioidosis. The investigators also predict that the prevention programme of melioidosis will also prevent other common infectious diseases with have similar routes of infection, such as leptospirosis and acute diarrhea. The outcome of the RCT will be crucial evidence for the Ministry of Public Health (MoPH) Thailand for their consideration of policy changes for the prevention of melioidosis countrywide.
The funder: Wellcome Trust. Grant reference number: 101103/Z/13/Z
Result:
Pubmed link: https://pubmed.ncbi.nlm.nih.gov/34170931/
PLoS NTD link: https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0009060
DOI: https://doi.org/10.1371/journal.pntd.0009060
MedRxiv: https://www.medrxiv.org/content/10.1101/2020.12.18.20248448v1
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cluster A | Other | Other: An educational programme for prevention of melioidosisGeneral education for prevention of diabetic complications in year 1, Melioidosis prevention education in years 2, 3 and 4. |
| Cluster B | Other | Other: An educational programme for prevention of melioidosisGeneral education for prevention of diabetic complications in year 1 and 2, Melioidosis prevention education in year 3 and 4. |
| Cluster C | Other | Other: An educational programme for prevention of melioidosisGeneral education for prevention of diabetic complications in year 1, 2 and 3, Melioidosis prevention education in year 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female (Include pregnant women) , aged from 18 to 65 years old
- Diagnosed of diabetes according to American Diabetes Association 2013 as following
- Oriented and conversed normally
- Willingness to participate in the study, and written, informed consent obtained from patient
Key exclusion criteria (2 listed)
- Confused or unable to communicate
- Diagnosed of melioidosis and has not completed oral-eradicative treatment for melioidosis
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 |
|---|---|---|
| An educational programme for prevention of melioidosisThe intervention will be randomly implemented at 10, 10 and 10 diabetic clinics at the end of years 1, 2 and 3, respectively. The education will be conducted using small group education, in which 20 to 25 participants at a time will attend group sessions conducted by the study team. | Other | Cluster A, Cluster B, Cluster C |
Primary outcome
Overall hospital admissions due to infectious diseases
Time frame: Up to 4 years
Infectious diseases will be determined by International Classification of Disease 10 (ICD10) defined by attending physicians.
Culture-confirmed melioidosis
Time frame: Up to 4 years
Culture-confirmed melioidosis is defined as presentation with clinical features of melioidosis in association with cultures from any clinical specimen positive for Burkholderia pseudomallei.
2 secondary outcomes
Overall mortality
Time frame: Up to 4 years
Overall melioidosis
Time frame: Up to 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 21 Jul 2021.
- Background: PubMed 20519609Limmathurotsakul D, Wongratanacheewin S, Teerawattanasook N, Wongsuvan G, Chaisuksant S, Chetchotisakd P, Chaowagul W, Day NP, Peacock SJ. Increasing incidence of human melioidosis in Northeast Thailand. Am J Trop Med Hyg. 2010 Jun;82(6):1113-7. doi: 10.4269/ajtmh.2010.10-0038.
- Background: PubMed 21558159Limmathurotsakul D, Peacock SJ. Melioidosis: a clinical overview. Br Med Bull. 2011;99:125-39. doi: 10.1093/bmb/ldr007. Epub 2011 May 9.
- Background: PubMed 19121666Currie BJ, Dance DA, Cheng AC. The global distribution of Burkholderia pseudomallei and melioidosis: an update. Trans R Soc Trop Med Hyg. 2008 Dec;102 Suppl 1:S1-4. doi: 10.1016/S0035-9203(08)70002-6.
- Background: PubMed 23556010Limmathurotsakul D, Dance DA, Wuthiekanun V, Kaestli M, Mayo M, Warner J, Wagner DM, Tuanyok A, Wertheim H, Yoke Cheng T, Mukhopadhyay C, Puthucheary S, Day NP, Steinmetz I, Currie BJ, Peacock SJ. Systematic review and consensus guidelines for environmental sampling of Burkholderia pseudomallei. PLoS Negl Trop Dis. 2013;7(3):e2105. doi: 10.1371/journal.pntd.0002105. Epub 2013 Mar 21.
- Background: PubMed 7860160Suputtamongkol Y, Hall AJ, Dance DA, Chaowagul W, Rajchanuvong A, Smith MD, White NJ. The epidemiology of melioidosis in Ubon Ratchatani, northeast Thailand. Int J Epidemiol. 1994 Oct;23(5):1082-90. doi: 10.1093/ije/23.5.1082.
- Background: PubMed 12206383Faa AG, Holt PJ. Melioidosis in the Torres Strait islands of far North Queensland. Commun Dis Intell Q Rep. 2002;26(2):279-83. doi: 10.33321/cdi.2002.26.26.
- Background: PubMed 23437412Limmathurotsakul D, Kanoksil M, Wuthiekanun V, Kitphati R, deStavola B, Day NP, Peacock SJ. Activities of daily living associated with acquisition of melioidosis in northeast Thailand: a matched case-control study. PLoS Negl Trop Dis. 2013;7(2):e2072. doi: 10.1371/journal.pntd.0002072. Epub 2013 Feb 21.
- Background: PubMed 24447771Limmathurotsakul D, Wongsuvan G, Aanensen D, Ngamwilai S, Saiprom N, Rongkard P, Thaipadungpanit J, Kanoksil M, Chantratita N, Day NP, Peacock SJ. Melioidosis caused by Burkholderia pseudomallei in drinking water, Thailand, 2012. Emerg Infect Dis. 2014 Feb;20(2):265-8. doi: 10.3201/eid2002.121891.
- BackgroundWongsuvan N, Malasit M, Hongsuwan M, et al. Defining beliefs and environmental contraints on prevention of melioidosis in northeast Thailand. 2013. (manuscript under preparation)
- BackgroundLimmathurosakul D, Lubell Y, Day N, Peacock N. Modelling the cost-effectiveness of strategies to prevent melioidosis in northeast Thailand. 2013. (manuscript under preparation)
- Background: PubMed 2708842Chaowagul W, White NJ, Dance DA, Wattanagoon Y, Naigowit P, Davis TM, Looareesuwan S, Pitakwatchara N. Melioidosis: a major cause of community-acquired septicemia in northeastern Thailand. J Infect Dis. 1989 May;159(5):890-9. doi: 10.1093/infdis/159.5.890.
- Background: PubMed 2665001Leelarasamee A, Bovornkitti S. Melioidosis: review and update. Rev Infect Dis. 1989 May-Jun;11(3):413-25. doi: 10.1093/clinids/11.3.413.
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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.
Assist Prof. Direk Limmathurotsakul, M.D. principal investigator
Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An educational programme for prevention of melioidosis in people with Melioidosis, run by University of Oxford at 1 site in Thailand.
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 8 inclusion and 2 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 21 Jul 2021. 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 Thailand. 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?
Overall hospital admissions due to infectious diseases (time frame: Up to 4 years). The study lists 2 primary outcomes in all. 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 NCT02089152, which also lists 18 linked publications.
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 21 Jul 2021; AzTrials last refreshed its copy on 30 Oct 2026.