Scrub Typhus Pediatric Immunology Study

NCT02398162 | Completed

• 1 other identifier: MICRO1402
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study of the natural immune response to scrub typhus in patients recruited from Chiangrai Prachanukroh Hospital, N-Thailand. Febrile patients with a positive IgM rapid diagnostic test will be asked if they wish to take part in a study to improve the understanding of how the body responds to scrub typhus. Blood samples will be collected from each participant ("STP", n=60) at baseline (the day of presentation to hospital), 2 weeks later in hospital, 12 weeks after baseline at the clinic visit and 1 year later. Data on clinical presentation and relapses will be recorded. Control subjects are scrub typhus exposed patients from a rural village in the caption area of Prachanukroh Hospital ("STE", n=80; approx. 40 children and 40 adults), and healthy adults blood donors from Bangkok ("STH" n=30) - these subjects will be enrolled for one single blood sample. The study team will also collect eschar swab specimens from STP group and a non-invasive specimen of the dark crust on the day of enrollment. Funder: Li Ka Shing Foundation \[Grant C13004\]

Conditions

Scrub Typhus

Keywords

Scrub Typhus in Pediatric; Immunology

Outcome Measures

Primary Outcomes (1)

• Cellular immune response to Orientia tsutsugamushi

  Characterize the cellular immune response to Orientia tsutsugamushi, based on immune cell phenotyping and quantitation of effector, memory \& regulatory T cell functions.

  2 years

Secondary Outcomes (3)

• T-cell subsets during the scrub typhus infection

  2 years

• Antibody isotypes during the scrub typhus infection

  2 years

• Adaptive immune response to Orientia tsutsugamushi

  2 years

Study Arms (3)

STP

Scrub Typhus Patients (STP, n=60) Cohort. Blood samples will be collected at baseline (the day of presentation to hospital), 2 weeks later in hospital, 12 weeks after baseline at the clinic visit and 1 year later. Data on clinical presentation and relapses will be recorded. Eschar swab specimens and a non-invasive specimen of the dark crust will be also collected from STP group on the day of enrollment.

Procedure: Multi Blood Collections

STE

Scrub Typhus Exposed (STE, n=80) Cohort. Single blood sample collection.

Procedure: Single Blood Collection

STH

Scrub Typhus Healthy (STH, n=30) Cohort. Single blood sample collection

Procedure: Single Blood Collection

Interventions

Multi Blood Collections PROCEDURE

At baseline (the day of presentation to hospital), 2 weeks, 12 weeks and 1 year later.

STP

Single Blood Collection PROCEDURE

On the enrollment day

STE; STH

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases: Male and female patients ≤ 18 years of age with acute scrub typhus (n=60). Controls: people exposed to scrub typhus (approx. 40 children and 40 adults from Chiangrai, total n=80) preferably age-matched, healthy and non-febrile, and healthy adult scrub typhus-naïve controls from Bangkok (n=30), total n=170.

You may qualify if:

• Age \>6 months to ≤18 years (STP consist of pediatrics only)
• Scrub Typhus Rapid test positivity (SDm Standard Diagnostics RDT, Korea)
• O. tsutsugamushi PCR-positivity (if PCR capability is available by the start of the study)
• Fever in ≤ 14 days of presentation to Hospital
• Willingness to participate in the study and written informed assent previously obtained from the patient, and written informed consent obtained from the patient's parent(s), guardian(s) or representative(s)
• Age \>6 months to ≤18 years and age \>18 years (STE consist of paediatrics and adult )
• Historical diagnosis of scrub typhus, as defined by rapid diagnostic test, serology and/or PCR positivity (more than 2 years ago), or living in an endemic area with high risk of previous exposure.
• Currently well and healthy
• Willingness to participate in the study and written informed assent previously obtained from the patient, and written informed consent obtained from the patient's parent(s), guardian(s) or representative(s)
• Age \>18 years (STH consist of adults only)
• Currently well, no medical problems requiring hospital specialist supervision
• Willingness to participate in the study and written, informed consent previously obtained
• Residing in Bangkok for at least the 2 past recent years

You may not qualify if:

• Current TB or TB treatment in ≤ 6 months (contains Orientia-effective antimicrobial)
• Documented HIV infection, use of steroids, chemotherapy, other immunosuppressant therapy or herbal remedies containing steroids and/or pregnancy
• Significant acute intercurrent illness at the time of blood draw including fever \>37.5°C or infection (including TB) requiring antibiotics
• Documented HIV infection, use of steroids, chemotherapy, other immunosuppressant therapy or herbal remedies containing steroids and/or pregnancy
• Previous history of scrub typhus
• Significant acute intercurrent illness at the time of blood draw including fever \>37.5°C or infection (including TB) requiring antibiotics
• Documented HIV infection, use of steroids, chemotherapy, other immunosuppressant therapy or herbal remedies containing steroids and/or pregnancy

Sponsors & Collaborators

• University of Oxford: lead
• Li Ka Shing Foundation: collaborator
• Mahidol University: collaborator
• Chiangrai Prachanukroh Hospital: collaborator

Study Sites (1)

Chiangrai Prachanukroh Hospital

Chiang Rai, Thailand

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

• Dr.Daniel Paris, MD

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 25, 2015
• Study Start: July 15, 2015
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: September 20, 2018

Record last verified: 2018-08

Locations

TH (1)