Scrub Typhus Clinical Trial
— NIRPSOfficial title:
The Natural Immune Response In Pediatric Scrub Typhus In Chiangrai
NCT number | NCT02398162 |
Other study ID # | MICRO1402 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 15, 2015 |
Est. completion date | October 17, 2017 |
Verified date | August 2018 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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]
Status | Completed |
Enrollment | 170 |
Est. completion date | October 17, 2017 |
Est. primary completion date | October 17, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Scrub Typhus Patients (STP) Cohort inclusion criteria - 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) Scrub Typhus Exposed (STE) Cohort inclusion criteria - 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) Scrub Typhus Healthy (STH) Cohorts inclusion criteria - 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 Exclusion Criteria: Scrub Typhus Patients (STP) Cohort exclusion criteria: - 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 Scrub Typhus Exposed (STE) Cohort exclusion criteria: - 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 Scrub Typhus Healthy (STH) Cohorts exclusion criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Chiangrai Prachanukroh Hospital | Chiang Rai |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Chiangrai Prachanukroh Hospital, Li Ka Shing Foundation, Mahidol University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | T-cell subsets during the scrub typhus infection | Identification of T-cell subsets affected by apoptosis during the course of acute scrub typhus. | 2 years | |
Secondary | Antibody isotypes during the scrub typhus infection | Determination of the antibody isotypes and their dynamics involved in natural scrub typhus infection. | 2 years | |
Secondary | Adaptive immune response to Orientia tsutsugamushi | Characterisation of the adaptive immune response to Orientia tsutsugamushi, measured by ex vivo interferon-gamma ELISPOT in spot forming cells per million peripheral blood mononuclear cells (SFC/106PBMC), using four Orientia antigens (whole cell antigen, 56kDa, 47kDa and scaC) in samples of acute disease and long term follow up. | 2 years |
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