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Trial record 2 of 2 for:    19087314 [PUBMED-IDS]

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 (PREMEL)

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ClinicalTrials.gov Identifier: NCT02089152
Recruitment Status : Active, not recruiting
First Posted : March 17, 2014
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief 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 behaviour change trial in 9,000 diabetics in Ubon Ratchathani, northeast Thailand.


Condition or disease Intervention/treatment Phase
Melioidosis Other: An educational programme for prevention of melioidosis Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9076 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : April 1, 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cluster A
General education for prevention of diabetic complications in year 1, Melioidosis prevention education in years 2, 3 and 4.
Other: An educational programme for prevention of melioidosis
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.

Cluster B
General education for prevention of diabetic complications in year 1 and 2, Melioidosis prevention education in year 3 and 4.
Other: An educational programme for prevention of melioidosis
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.

Cluster C
General education for prevention of diabetic complications in year 1, 2 and 3, Melioidosis prevention education in year 4.
Other: An educational programme for prevention of melioidosis
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Overall mortality [ Time Frame: Up to 4 years ]
    Overall mortality is defined as death from all causes.

  2. Overall melioidosis [ Time Frame: Up to 4 years ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Confused or unable to communicate
  • Diagnosed of melioidosis and has not completed oral-eradicative treatment for melioidosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089152


Locations
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Thailand
Sappasithiprasong Hospital
Ubon Ratchathani, Thailand, 34000
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Assist Prof. Direk Limmathurotsakul, M.D. Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand

Publications:
Wongsuvan 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)

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02089152     History of Changes
Other Study ID Numbers: MICRO1307
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Keywords provided by University of Oxford:
Diabetes
Melioidosis
stepped wedge trial
behaviour change
Education program
Additional relevant MeSH terms:
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Melioidosis
Burkholderia Infections
Gram-Negative Bacterial Infections
Bacterial Infections