Scrub Typhus RDT Study

Summary

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.

Conditions

• The Prevalence of Scrub Typhus

Interventions

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.

Sponsors & Collaborators

• University of Oxford

  collaborator OTHER

• Medical Action Myanmar

  collaborator OTHER

• Yae Township Hospital, Mon State

  collaborator UNKNOWN

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• Defence Services Medical Academy (DSMA), Myanmar

  collaborator UNKNOWN

• Myanmar Oxford Clinical Research Unit

  lead OTHER

Principal Investigators

• Elizabeth Anne Ashley, Dr · Myanmar Oxford Clinical Research Unit

• Ni Ni Tun, Dr · Medical Action Myanmar

• Aye Thida Aye, Dr · Yae Township Hospital, Mon State

• Kyaw Myo Tun, Dr · Defence Services Medical Academy (DSMA)

• Khine Khine Su, Prof · Defence Services Medical Academy (DSMA)

• James Heaton, Dr · Myanmar Oxford Clinical Research Unit

• Kyaw Soe · Myanmar Oxford Clinical Research Unit

• Daniel Paris, Prof · Swiss Tropical & Public Health Institute

• Frank Smithuis, Prof · Myanmar Oxford Clinical Research Unit and Medical Action Myanmar

• Myo Mg Mg Swe, Dr · Myanmar Oxford Clinical Research Unit

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-04

Primary Completion

2019-12-26

Completion

2019-12-26

Countries

• Burma

Study Locations