Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Oxford

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall mortality [ Time Frame: Up to 4 years ]
    Overall mortality is defined as death from all causes.
  • 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.


Original Secondary Outcome: Same as current

Information By: University of Oxford

Dates:
Date Received: March 13, 2014
Date Started: April 2014
Date Completion: August 2018
Last Updated: August 24, 2016
Last Verified: August 2016