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Scrub Typhus RDT Study

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ClinicalTrials.gov Identifier: NCT03269266
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : January 8, 2018
Sponsor:
Collaborators:
University of Oxford
Medical Action Myanmar (MAM)
Yae Township Hospital, Mon State
Swiss Tropical & Public Health Institute
Defence Services Medical Academy (DSMA), Myanmar
Information provided by (Responsible Party):
Myanmar Oxford Clinical Research Unit

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.


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
Observational Model: Other
Time Perspective: Prospective
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 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever


Intervention Details:
  • 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.



Primary Outcome Measures :
  1. Positive RDT Result [ Time Frame: 15 Minutes ]
    Proportion of patients with a positive RDT result


Secondary Outcome Measures :
  1. 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)

  2. Fever/symptom resolution [ Time Frame: One Week ]
    Proportion of patients with fever/symptom resolution at one week



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with fever (± eschar) presenting to community health clinics/hospitals in Myanmar
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT03269266


Contacts
Contact: Elizabeth Anne Ashley, Dr + 95 (1) 544 537 liz@tropmedres.ac
Contact: Htet Htet Aung, BA +95 (1) 544 537 htethtetaung@mocru.org.mm

Locations
Myanmar
No.20, 100 Bedded Military Hospital, Recruiting
Thabeikkyin, Mandalay, Myanmar
Contact: Thurein Kyaw, Dr         
Contact: Kyaw Myo Tun, Dr         
No.2, 1000 Bedded Military Hospital Recruiting
Nay Pyi Taw, Myanmar
Contact: Phone Myint Maung, Dr         
Contact: Kyaw Myo Tun, Dr         
Sponsors and Collaborators
Myanmar Oxford Clinical Research Unit
University of Oxford
Medical Action Myanmar (MAM)
Yae Township Hospital, Mon State
Swiss Tropical & Public Health Institute
Defence Services Medical Academy (DSMA), Myanmar
Investigators
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

Responsible Party: Myanmar Oxford Clinical Research Unit
ClinicalTrials.gov Identifier: NCT03269266     History of Changes
Other Study ID Numbers: OXTREC 18-17
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: November 2017

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:
Scrub Typhus
Positive Rapid Diagnostic Test

Additional relevant MeSH terms:
Typhus, Epidemic Louse-Borne
Scrub Typhus
Rickettsia Infections
Rickettsiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections