We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rickettsiae in Myanmar (Rickettsiae)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03847870
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
National Health Laboratory, Myanmar
Magway General Hospital, Magway
Monywa Hospital, Sagaing
Mandalay General Hospital and University of Medicine, Mandalay
University of Medicine, Magway
Mahidol Oxford Tropical Medicine Research Unit
Medical Action Myanmar
Information provided by (Responsible Party):
Myanmar Oxford Clinical Research Unit

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Rickettsiae Infections Diagnostic Test: MORU in-house ELISA test followed by IFA if positive

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 700 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Background Seroprevalence of Rickettsial Infections in Myanmar
Actual Study Start Date : June 20, 2019
Actual Primary Completion Date : October 25, 2019
Actual Study Completion Date : October 25, 2019
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Diagnostic Test: 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.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847870


Locations
Layout table for location information
Myanmar
Myanmar Oxford Clinical Research Unit
Yangon, Myanmar
Sponsors and Collaborators
Myanmar Oxford Clinical Research Unit
National Health Laboratory, Myanmar
Magway General Hospital, Magway
Monywa Hospital, Sagaing
Mandalay General Hospital and University of Medicine, Mandalay
University of Medicine, Magway
Mahidol Oxford Tropical Medicine Research Unit
Medical Action Myanmar
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Myanmar Oxford Clinical Research Unit
ClinicalTrials.gov Identifier: NCT03847870    
Other Study ID Numbers: OXTREC 552-18
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Myanmar Oxford Clinical Research Unit:
rickettsiae
seroprevalence
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Rickettsia Infections
Rickettsiaceae Infections
Gram-Negative Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Vector Borne Diseases