Clinical trial NCT02089152: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melioidosis
Keywords: Diabetes
Melioidosis
stepped wedge trial
behaviour change
Education program
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 9075
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Eligibility 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

Primary outcomes:
measure: Overall hospital admissions due to infectious diseases
timeFrame: Up to 4 years
measure: Culture-confirmed melioidosis
timeFrame: Up to 4 years
Secondary outcomes:
measure: Overall mortality
timeFrame: Up to 4 years
measure: Overall melioidosis
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Ubon Ratchathani
country: Thailand
facility: Sappasithiprasong Hospital
Study officials:
affiliation: Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand
name: Assist Prof. Direk Limmathurotsakul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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