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)

July 14, 2021 updated by: University of Oxford

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9075

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Ubon Ratchathani, Thailand, 34000
        • Sappasithiprasong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 years
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.
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall mortality
Time Frame: Up to 4 years
Overall mortality is defined as death from all causes.
Up to 4 years
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.
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Assist Prof. Direk Limmathurotsakul, M.D., Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 17, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICRO1307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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