Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
700 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-06-20
Study Completion Date
2019-10-25
Brief Summary
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Rickettsial infections have been found to be the second most common cause of non-malarial febrile illness in Southeast Asia, just after dengue, and are largely neglected treatable causes of morbidity and mortality. The rickettsiae can be divided into three major groups: the scrub typhus group (STG), the typhus group (TG) and the spotted fever group (SFG). Rickettsial infections typically present with an acute fever and are difficult to diagnose due to the many different causes of undifferentiated fever in Southeast Asia. Rickettsial IgG seroprevalence, reflecting past infection, will give an estimate of the burden of rickettsial infections in the population. Background seroprevalence studies in countries around Myanmar have found high rates of rickettsial infections. Yet, in Myanmar there have been no prevalence studies on rickettsial infections since the Second World War. We plan to determine IgG levels to the three different groups of rickettsial infections in leftover blood samples in several clinics and hospitals in different regions of Myanmar.
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Detailed Description
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Rickettsial infections have been found to be the second most common cause of non-malarial febrile illness in Southeast Asia, just after dengue, and are largely neglected treatable causes of morbidity and mortality. The rickettsiae can be divided into three major groups: the scrub typhus group (STG), the typhus group (TG) and the spotted fever group (SFG). Rickettsial infections typically present with an acute fever and are difficult to diagnose due to the many different causes of undifferentiated fever in Southeast Asia. Rickettsial IgG seroprevalence, reflecting past infection, will give an estimate of the burden of rickettsial infections in the population. The current best test for IgG serological diagnosis of previous rickettsial infections is the indirect immunofluorescence assay (IFA). IFA has several limitations
in that it is difficult to standardize due to operator subjectivity, it needs appropriate local diagnostic cut- offs and requires improvement in terms of standardization and ease of use. An alternative serological test that is cheaper and is easier to use is the enzyme-linked immunosorbent assay (ELISA), which is more suited to screen for the burden of rickettsial diseases in low-resource countries. Background seroprevalence studies in countries around Myanmar have found high rates of rickettsial infections. Yet, in Myanmar there have been no prevalence studies on rickettsial infections since the Second World War. We plan to determine IgG levels to the three different groups of rickettsial infections in leftover blood samples in several clinics and hospitals in different regions of Myanmar. Participants with leftover blood samples after having undergone a blood draw for any clinical reason or a blood donation will be requested to participate in the study. The participant will be informed about the study and requested to provide informed consent when agreeing to participate. The leftover sample will be anonymized and frozen. The gender, age and location of clinic/hospital of the participant will be recorded. All samples will be tested for IgG antibodies using an in-house ELISA test in the Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand for scrub typhus (Orientia tsutsugamushi strains Karp, Kato, Gilliam and TA716), murine typhus (Rickettsia typhi strain type Wilmington), and spotted fever rickettsioses (Rickettsia honei and Rickettsia conorii). If the sample tests positive for IgG antibodies, an IFA test will be performed as the gold standard reference test to confirm the finding. The anonymous samples will be discarded as soon as they are no longer needed for the study. The population investigated will be 700 patients attending seven different clinics and hospitals in different regions of Myanmar with each site including 100 patients.
We will include patients at the following study sites:
1. Himalaya general clinic, Puta-O, Kachin;
2. Lily general clinic, Thanbyuzayat, Mon;
3. Orchid general clinic, Hlaing Thar Yar, Yangon;
4. Winka general clinic, Winka, Kayin;
5. Monywa Hospital, Sagaing;
6. Mandalay General Hospital and University of Medicine, Mandalay;
7. Magway General Hospital, Magway This is a minimal risk study. The participants will not have to undergo any additional procedures, since we will be using leftover blood samples that have been collected for routine clinical tests to study the background levels of previous rickettsial infections. Participation in this study is voluntary. Subjects who decline to participate will have no impact on the care they receive at the hospital or clinic. There will be no incentives or compensation for study participation.
in that it is difficult to standardize due to operator subjectivity, it needs appropriate local diagnostic cut- offs and requires improvement in terms of standardization and ease of use. An alternative serological test that is cheaper and is easier to use is the enzyme-linked immunosorbent assay (ELISA), which is more suited to screen for the burden of rickettsial diseases in low-resource countries. Background seroprevalence studies in countries around Myanmar have found high rates of rickettsial infections. Yet, in Myanmar there have been no prevalence studies on rickettsial infections since the Second World War. We plan to determine IgG levels to the three different groups of rickettsial infections in leftover blood samples in several clinics and hospitals in different regions of Myanmar. Participants with leftover blood samples after having undergone a blood draw for any clinical reason or a blood donation will be requested to participate in the study. The participant will be informed about the study and requested to provide informed consent when agreeing to participate. The leftover sample will be anonymized and frozen. The gender, age and location of clinic/hospital of the participant will be recorded. All samples will be tested for IgG antibodies using an in-house ELISA test in the Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand for scrub typhus (Orientia tsutsugamushi strains Karp, Kato, Gilliam and TA716), murine typhus (Rickettsia typhi strain type Wilmington), and spotted fever rickettsioses (Rickettsia honei and Rickettsia conorii). If the sample tests positive for IgG antibodies, an IFA test will be performed as the gold standard reference test to confirm the finding. The anonymous samples will be discarded as soon as they are no longer needed for the study. The population investigated will be 700 patients attending seven different clinics and hospitals in different regions of Myanmar with each site including 100 patients.
We will include patients at the following study sites:
1. Himalaya general clinic, Puta-O, Kachin;
2. Lily general clinic, Thanbyuzayat, Mon;
3. Orchid general clinic, Hlaing Thar Yar, Yangon;
4. Winka general clinic, Winka, Kayin;
5. Monywa Hospital, Sagaing;
6. Mandalay General Hospital and University of Medicine, Mandalay;
7. Magway General Hospital, Magway This is a minimal risk study. The participants will not have to undergo any additional procedures, since we will be using leftover blood samples that have been collected for routine clinical tests to study the background levels of previous rickettsial infections. Participation in this study is voluntary. Subjects who decline to participate will have no impact on the care they receive at the hospital or clinic. There will be no incentives or compensation for study participation.
Conditions
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Rickettsiae Infections
Study Design
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Observational Model Type
OTHER
Study Time Perspective
CROSS_SECTIONAL
Interventions
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MORU in-house ELISA test followed by IFA if positive
An in-house rickettsial IgG ELISA test will be used for this study to determine previous rickettsial infections by measuring IgG levels. All specimens will be tested for IgG antibodies using ELISA tests for scrub typhus (Orientia tsutsugamushi strains Karp, Kato, Gilliam and TA716), murine typhus (Rickettsia typhi strain type Wilmington), and spotted fever rickettsiosis (Rickettsia honei and Rickettsia conorii). If the sample tests positive, it will be retested for the same antigens using the IFA test. The sample will be considered positive if both the ELISA and the IFA are positive.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
* Male and female, all age groups, requiring a blood draw for a routine clinical purpose
Exclusion Criteria
* Leftover blood sample of less than 500μL
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Health Laboratory, Myanmar
UNKNOWN
Sponsor Role
collaborator
Magway General Hospital, Magway
UNKNOWN
Sponsor Role
collaborator
Monywa Hospital, Sagaing
UNKNOWN
Sponsor Role
collaborator
Mandalay General Hospital and University of Medicine, Mandalay
UNKNOWN
Sponsor Role
collaborator
University of Medicine, Magway
UNKNOWN
Sponsor Role
collaborator
Mahidol Oxford Tropical Medicine Research Unit
OTHER
Sponsor Role
collaborator
Medical Action Myanmar
OTHER
Sponsor Role
collaborator
Myanmar Oxford Clinical Research Unit
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Elizabeth Anne Ashley, Dr
Role: PRINCIPAL_INVESTIGATOR
Myanmar Oxford Clinical Research Unit
Stuart Blacksell, Prof
Role: PRINCIPAL_INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit
Philip Elders, MSc
Role: STUDY_DIRECTOR
Myanmar Oxford Clinical Research Unit
Wei Yan Aung Htay, Dr
Role: STUDY_DIRECTOR
Myanmar Oxford Clinical Research Unit
Yin Yin Htwe, Dr
Role: STUDY_DIRECTOR
National Health Laboratory, Myanmar
Myat Myat Moe, Dr
Role: STUDY_DIRECTOR
Magway General Hospital, Magway
Wai Mon Kyaw, Dr
Role: STUDY_DIRECTOR
Monywa Hospital, Sagaing
Ni Ni Zaw, Dr
Role: STUDY_DIRECTOR
Mandalay General Hospital and University of Medicine, Mandalay
Win May Thein, Prof
Role: STUDY_DIRECTOR
Mandalay General Hospital and University of Medicine, Mandalay
Thin Thin Nwe, Prof
Role: STUDY_DIRECTOR
University of Medicine, Magway
Kyaw Soe, BSc
Role: STUDY_DIRECTOR
Myanmar Oxford Clinical Research Unit
Ampai Tanganuchitcharnchai, BSc
Role: STUDY_DIRECTOR
Mahidol Oxford Tropical Medicine Research Unit
Ni Ni Tun, Dr
Role: STUDY_DIRECTOR
Myanmar Oxford Clinical Research Unit and Medical Action Myanmar
Frank Smithuis, Prof
Role: STUDY_DIRECTOR
Myanmar Oxford Clinical Research Unit and Medical Action Myanmar
Locations
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Myanmar Oxford Clinical Research Unit
Yangon, , Burma
Site Status
Countries
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Burma
References
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Acestor N, Cooksey R, Newton PN, Menard D, Guerin PJ, Nakagawa J, Christophel E, Gonzalez IJ, Bell D. Mapping the aetiology of non-malarial febrile illness in Southeast Asia through a systematic review--terra incognita impairing treatment policies. PLoS One. 2012;7(9):e44269. doi: 10.1371/journal.pone.0044269. Epub 2012 Sep 6.
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Aung AK, Spelman DW, Murray RJ, Graves S. Rickettsial infections in Southeast Asia: implications for local populace and febrile returned travelers. Am J Trop Med Hyg. 2014 Sep;91(3):451-60. doi: 10.4269/ajtmh.14-0191. Epub 2014 Jun 23.
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Walker DH. Rickettsial diseases in travelers. Travel Med Infect Dis. 2003 Feb;1(1):35-40. doi: 10.1016/S1477-8939(03)00025-5.
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Taylor AJ, Paris DH, Newton PN. A Systematic Review of Mortality from Untreated Scrub Typhus (Orientia tsutsugamushi). PLoS Negl Trop Dis. 2015 Aug 14;9(8):e0003971. doi: 10.1371/journal.pntd.0003971. eCollection 2015.
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Civen R, Ngo V. Murine typhus: an unrecognized suburban vectorborne disease. Clin Infect Dis. 2008 Mar 15;46(6):913-8. doi: 10.1086/527443.
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Uchiyama T. Tropism and pathogenicity of rickettsiae. Front Microbiol. 2012 Jun 25;3:230. doi: 10.3389/fmicb.2012.00230. eCollection 2012.
Reference Type
BACKGROUND
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Reference Type
BACKGROUND
Blacksell SD, Lim C, Tanganuchitcharnchai A, Jintaworn S, Kantipong P, Richards AL, Paris DH, Limmathurotsakul D, Day NPJ. Optimal Cutoff and Accuracy of an IgM Enzyme-Linked Immunosorbent Assay for Diagnosis of Acute Scrub Typhus in Northern Thailand: an Alternative Reference Method to the IgM Immunofluorescence Assay. J Clin Microbiol. 2016 Jun;54(6):1472-1478. doi: 10.1128/JCM.02744-15. Epub 2016 Mar 23.
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BACKGROUND
Phetsouvanh R, Thojaikong T, Phoumin P, Sibounheuang B, Phommasone K, Chansamouth V, Lee SJ, Newton PN, Blacksell SD. Inter- and intra-operator variability in the reading of indirect immunofluorescence assays for the serological diagnosis of scrub typhus and murine typhus. Am J Trop Med Hyg. 2013 May;88(5):932-936. doi: 10.4269/ajtmh.12-0325. Epub 2013 Mar 11.
Reference Type
BACKGROUND
Blacksell SD, Bryant NJ, Paris DH, Doust JA, Sakoda Y, Day NP. Scrub typhus serologic testing with the indirect immunofluorescence method as a diagnostic gold standard: a lack of consensus leads to a lot of confusion. Clin Infect Dis. 2007 Feb 1;44(3):391-401. doi: 10.1086/510585. Epub 2007 Jan 3.
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BACKGROUND
Blacksell SD, Tanganuchitcharnchai A, Nawtaisong P, Kantipong P, Laongnualpanich A, Day NP, Paris DH. Diagnostic Accuracy of the InBios Scrub Typhus Detect Enzyme-Linked Immunoassay for the Detection of IgM Antibodies in Northern Thailand. Clin Vaccine Immunol. 2015 Dec 9;23(2):148-54. doi: 10.1128/CVI.00553-15. Print 2016 Feb.
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BACKGROUND
Blacksell SD, Kingston HWF, Tanganuchitcharnchai A, Phanichkrivalkosil M, Hossain M, Hossain A, Ghose A, Leopold SJ, Dondorp AM, Day NPJ, Paris DH. Diagnostic Accuracy of the InBios Scrub Typhus Detect ELISA for the Detection of IgM Antibodies in Chittagong, Bangladesh. Trop Med Infect Dis. 2018 Sep 1;3(3):95. doi: 10.3390/tropicalmed3030095.
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BACKGROUND
Lim C, Paris DH, Blacksell SD, Laongnualpanich A, Kantipong P, Chierakul W, Wuthiekanun V, Day NP, Cooper BS, Limmathurotsakul D. How to Determine the Accuracy of an Alternative Diagnostic Test when It Is Actually Better than the Reference Tests: A Re-Evaluation of Diagnostic Tests for Scrub Typhus Using Bayesian LCMs. PLoS One. 2015 May 29;10(5):e0114930. doi: 10.1371/journal.pone.0114930. eCollection 2015.
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Pote K, Narang R, Deshmukh P. Diagnostic performance of serological tests to detect antibodies against acute scrub typhus infection in central India. Indian J Med Microbiol. 2018 Jan-Mar;36(1):108-112. doi: 10.4103/ijmm.IJMM_17_405.
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Rawat V, Singh RK, Kumar A, Singh Y, Chaturvedi P, Saxena SR, Varshney U. Diagnostic validation of IgM and IgG ELISA and real-time PCR in detecting scrub typhus infection in endemic regions. J Vector Borne Dis. 2018 Apr-Jun;55(2):165-167. doi: 10.4103/0972-9062.242565. No abstract available.
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Yang SL, Tsai KH, Chen HF, Luo JY, Shu PY. Evaluation of Enzyme-Linked Immunosorbent Assay Using Recombinant 56-kDa Type-Specific Antigens Derived from Multiple Orientia tsutsugamushi Strains for Detection of Scrub Typhus Infection. Am J Trop Med Hyg. 2019 Mar;100(3):532-539. doi: 10.4269/ajtmh.18-0391.
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Tshokey T, Stenos J, Durrheim DN, Eastwood K, Nguyen C, Graves SR. Seroprevalence of rickettsial infections and Q fever in Bhutan. PLoS Negl Trop Dis. 2017 Nov 27;11(11):e0006107. doi: 10.1371/journal.pntd.0006107. eCollection 2017 Nov.
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Maude RR, Maude RJ, Ghose A, Amin MR, Islam MB, Ali M, Bari MS, Majumder MI, Tanganuchitcharnchai A, Dondorp AM, Paris DH, Bailey RL, Faiz MA, Blacksell SD, Day NPJ. Serosurveillance of Orientia tsutsugamushi and Rickettsia typhi in Bangladesh. Am J Trop Med Hyg. 2014 Sep;91(3):580-583. doi: 10.4269/ajtmh.13-0570. Epub 2014 Aug 4.
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MACKIE TT. Observations on tsutsugamushi disease (scrub typhus) in Assam and Burma. Trans R Soc Trop Med Hyg. 1946 Aug;40:15-56. doi: 10.1016/0035-9203(46)90061-2. No abstract available.
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Ellis RD, Fukuda MM, McDaniel P, Welch K, Nisalak A, Murray CK, Gray MR, Uthaimongkol N, Buathong N, Sriwichai S, Phasuk R, Yingyuen K, Mathavarat C, Miller RS. Causes of fever in adults on the Thai-Myanmar border. Am J Trop Med Hyg. 2006 Jan;74(1):108-13.
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Watthanaworawit W, Turner P, Turner C, Tanganuchitcharnchai A, Richards AL, Bourzac KM, Blacksell SD, Nosten F. A prospective evaluation of real-time PCR assays for the detection of Orientia tsutsugamushi and Rickettsia spp. for early diagnosis of rickettsial infections during the acute phase of undifferentiated febrile illness. Am J Trop Med Hyg. 2013 Aug;89(2):308-310. doi: 10.4269/ajtmh.12-0600. Epub 2013 Jun 3.
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BACKGROUND
McGready R, Ashley EA, Wuthiekanun V, Tan SO, Pimanpanarak M, Viladpai-Nguen SJ, Jesadapanpong W, Blacksell SD, Peacock SJ, Paris DH, Day NP, Singhasivanon P, White NJ, Nosten F. Arthropod borne disease: the leading cause of fever in pregnancy on the Thai-Burmese border. PLoS Negl Trop Dis. 2010 Nov 16;4(11):e888. doi: 10.1371/journal.pntd.0000888.
Reference Type
BACKGROUND
Other Identifiers
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OXTREC 552-18
Identifier Type: -
Identifier Source: org_study_id
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