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

Melioidosis Clinical Trial

— PREMEL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089152
• Other study ID #: MICRO1307
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9075
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Melioidosis

Intervention

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.

Locations

Country	Name	City	State
Thailand	Sappasithiprasong Hospital	Ubon Ratchathani

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

Thailand, 

References & Publications (17)

Bursac Z, Gauss CH, Williams DK, Hosmer DW. Purposeful selection of variables in logistic regression. Source Code Biol Med. 2008 Dec 16;3:17. doi: 10.1186/1751-0473-3-17. — View Citation

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. — View Citation

Cheng 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. — View Citation

Currie 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. — View Citation

Faa AG, Holt PJ. Melioidosis in the Torres Strait islands of far North Queensland. Commun Dis Intell Q Rep. 2002;26(2):279-83. — View Citation

Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. Review. — View Citation

Leelarasamee A, Bovornkitti S. Melioidosis: review and update. Rev Infect Dis. 1989 May-Jun;11(3):413-25. Review. — View Citation

Limmathurosakul D, Lubell Y, Day N, Peacock N. Modelling the cost-effectiveness of strategies to prevent melioidosis in northeast Thailand. 2013. (manuscript under preparation)

Limmathurotsakul 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. Review. — View Citation

Limmathurotsakul 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. — View Citation

Limmathurotsakul D, Peacock SJ. Melioidosis: a clinical overview. Br Med Bull. 2011;99:125-39. doi: 10.1093/bmb/ldr007. Epub 2011 May 9. Review. — View Citation

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. — View Citation

Limmathurotsakul 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. — View Citation

Michie 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. — View Citation

Moulton 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. — View Citation

Suputtamongkol 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. — View Citation

Wongsuvan N, Malasit M, Hongsuwan M, et al. Defining beliefs and environmental contraints on prevention of melioidosis in northeast Thailand. 2013. (manuscript under preparation)

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall hospital admissions due to infectious diseases	Infectious diseases will be determined by International Classification of Disease 10 (ICD10) defined by attending physicians.	Up to 4 years
Primary	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.	Up to 4 years
Secondary	Overall mortality	Overall mortality is defined as death from all causes.	Up to 4 years
Secondary	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.	Up to 4 years