Scrub Typhus RDT Study
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|ClinicalTrials.gov Identifier: NCT03269266|
Recruitment Status : Active, not recruiting
First Posted : August 31, 2017
Last Update Posted : January 9, 2019
Fever is one of most common presenting complaints in clinics in tropical countries. Rickettsial infections, enteric fever and leptospirosis are common and important causes of undifferentiated fever in Southeast Asia. Scrub typhus is caused by Orientia tsutsugamushi and humans are typically infected by a bite of an infected chigger (trombiculid mite larva). Clinical diagnosis is unreliable for identifying scrub typhus, unless a tick eschar is present which is almost pathognomonic for the disease in Southeast Asia. A combination of culture, paired serology and PCR has been proposed as the gold-standard method for detection. As a result laboratory confirmation is not widely available and the diagnosis is missed frequently in clinical practice. Some progress has been made in developing such a test and one promising candidate is the Scrub Typhus Detect IgM Rapid Test (InBios International Inc). We plan to use to this test in this study to estimate the prevalence of scrub typhus in selected febrile patients presenting to clinics in Myanmar .
Patients will be followed up for one week to check for resolution of symptoms.
|Condition or disease||Intervention/treatment|
|The Prevalence of Scrub Typhus||Diagnostic Test: Scrub Typhus RDT Test|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||A Multicentre Observational Study to Describe the Prevalence of Scrub Typhus Defined as a Positive Rapid Diagnostic Test Among Selected Patients Presenting With Fever to Clinics in Myanmar|
|Actual Study Start Date :||December 4, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
- Diagnostic Test: Scrub Typhus RDT Test
A transfer pipette or loop will be used to transfer 10 µL of whole blood from a finger prick to the sample pad area on the scrub typhus test strip and the test will be performed on site according to the manufacturer's instructions. Tests will be read by two independent readers and results recorded as positive, negative or invalid.
In patients with a skin eschar a sterile surgical blade will be used to gently scrape the surface of the eschar. Scrapings will be stored in a cryotube containing 95% ethanol and stored at -80°C for future analysis (PCR genotyping ± whole genome sequencing) to confirm the presence of Orientia tsutsugamushi.
- Positive RDT Result [ Time Frame: 15 Minutes ]Proportion of patients with a positive RDT result
- Inter-observer agreement expressed as the kappa statistic [ Time Frame: 15 Minutes ]Ease- of- use of the test (scored on blood safety, quality of instructions, number of timed steps to perform test, ease of interpretation, user satisfaction)
- Fever/symptom resolution [ Time Frame: One Week ]Proportion of patients with fever/symptom resolution at one week
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): NCT03269266
|No.20, 100 Bedded Military Hospital,|
|Thabeikkyin, Mandalay, Myanmar|
|No.2, 1000 Bedded Military Hospital|
|Nay Pyi Taw, Myanmar|
|Study Director:||Elizabeth Anne Ashley, Dr||Myanmar Oxford Clinical Research Unit|
|Study Director:||Ni Ni Tun, Dr||Medical Action Myanmar|
|Study Director:||Aye Thida Aye, Dr||Yae Township Hospital, Mon State|
|Study Director:||Kyaw Myo Tun, Dr||Defence Services Medical Academy (DSMA)|
|Study Director:||Khine Khine Su, Prof||Defence Services Medical Academy (DSMA)|
|Study Director:||James Heaton, Dr||Myanmar Oxford Clinical Research Unit|
|Study Director:||Kyaw Soe||Myanmar Oxford Clinical Research Unit|
|Study Director:||Daniel Paris, Prof||Swiss Tropical & Public Health Institute|
|Principal Investigator:||Frank Smithuis, Prof||Myanmar Oxford Clinical Research Unit and Medical Action Myanmar|
|Study Director:||Myo Mg Mg Swe, Dr||Myanmar Oxford Clinical Research Unit|