Scrub Typhus RDT Study

NCT03269266 | Completed

• 1 other identifier: OXTREC 18-17
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Scrub Typhus; Positive Rapid Diagnostic Test

Outcome Measures

Primary Outcomes (1)

• Positive RDT Result

  Proportion of patients with a positive RDT result

  15 Minutes

Secondary Outcomes (2)

• Inter-observer agreement expressed as the kappa statistic

  15 Minutes

• Fever/symptom resolution

  One Week

Interventions

Scrub Typhus RDT Test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with fever (± eschar) presenting to community health clinics/hospitals in Myanmar

You may qualify if:

• Male or female \>1 year of age
• Fever defined as \> 38 °C tympanic temperature
• Duration of fever (self-reported) \>48h
• Written informed consent (by parent or legally acceptable representative in case of children), and assent for children aged 10-17 years
• Eschar (60 patients only)

You may not qualify if:

• Malaria confirmed by RDT or microscopy
• Skin/soft tissue infection, dysentery or urinary tract infection probable cause of fever

Sponsors & Collaborators

• Myanmar Oxford Clinical Research Unit: lead
• University of Oxford: collaborator
• Medical Action Myanmar: collaborator
• Yae Township Hospital, Mon State: collaborator
• Swiss Tropical & Public Health Institute: collaborator
• Defence Services Medical Academy (DSMA), Myanmar: collaborator

Study Sites (2)

No.20, 100 Bedded Military Hospital,

Thabeikkyin, Mandalay Region, Burma

Location

No.2, 1000 Bedded Military Hospital

Nay Pyi Taw, Burma

Location

MeSH Terms

Conditions

Scrub Typhus

Condition Hierarchy (Ancestors)

Rickettsiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Study Officials

• 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

  STUDY DIRECTOR

• Frank Smithuis, Prof

  Myanmar Oxford Clinical Research Unit and Medical Action Myanmar

  PRINCIPAL INVESTIGATOR

• Myo Mg Mg Swe, Dr

  Myanmar Oxford Clinical Research Unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: December 4, 2017
• Primary Completion: December 26, 2019
• Study Completion: December 26, 2019
• Last Updated: January 13, 2020

Record last verified: 2019-01

Locations

BU (2)