Rickettsiae in Myanmar (Rickettsiae)

January 9, 2020 updated by: Myanmar Oxford Clinical Research Unit

Background Seroprevalence of Rickettsial Infections in Myanmar

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

700

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

  • Myanmar
      • Yangon, Myanmar
        • Myanmar Oxford Clinical Research Unit

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population investigated will be patients who had a leftover samples from routine clinical blood draw when attending seven different Medical Action Myanmar (MAM) clinics and hospitals in different regions of Myanmar with each site including approximately 100 patients.

Description

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

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive ELISA confirmed by positive IFA
Time Frame: January, 2020
Proportion of patients with a positive IgG ELISA, subsequently confirmed with IFA, 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 Ricketsia conorii).
January, 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient characteristics associated with rickettsial infections
Time Frame: January, 2020
Correlation of different patient characteristics with a positive ELISA and IFA test indicating a previous rickettsial infection.
January, 2020

Collaborators and Investigators

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

Sponsor

Myanmar Oxford Clinical Research Unit

Collaborators

Mahidol Oxford Tropical Medicine Research Unit
Medical Action Myanmar
National Health Laboratory, Myanmar
Magway General Hospital, Magway
Monywa Hospital, Sagaing
Mandalay General Hospital and University of Medicine, Mandalay
University of Medicine, Magway

Investigators

  • Principal Investigator: Elizabeth Anne Ashley, Dr, Myanmar Oxford Clinical Research Unit
  • Principal Investigator: Stuart Blacksell, Prof, Mahidol Oxford Tropical Medicine Research Unit
  • Study Director: Philip Elders, MSc, Myanmar Oxford Clinical Research Unit
  • Study Director: Wei Yan Aung Htay, Dr, Myanmar Oxford Clinical Research Unit
  • Study Director: Yin Yin Htwe, Dr, National Health Laboratory, Myanmar
  • Study Director: Myat Myat Moe, Dr, Magway General Hospital, Magway
  • Study Director: Wai Mon Kyaw, Dr, Monywa Hospital, Sagaing
  • Study Director: Ni Ni Zaw, Dr, Mandalay General Hospital and University of Medicine, Mandalay
  • Study Director: Win May Thein, Prof, Mandalay General Hospital and University of Medicine, Mandalay
  • Study Director: Thin Thin Nwe, Prof, University of Medicine, Magway
  • Study Director: Kyaw Soe, BSc, Myanmar Oxford Clinical Research Unit
  • Study Director: Ampai Tanganuchitcharnchai, BSc, Mahidol Oxford Tropical Medicine Research Unit
  • Study Director: Ni Ni Tun, Dr, Myanmar Oxford Clinical Research Unit and Medical Action Myanmar
  • Study Director: Frank Smithuis, Prof, Myanmar Oxford Clinical Research Unit and Medical Action Myanmar

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)

June 20, 2019

Primary Completion (Actual)

October 25, 2019

Study Completion (Actual)

October 25, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXTREC 552-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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