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Trial registered on ANZCTR


Registration number
ACTRN12615000202561
Ethics application status
Approved
Date submitted
17/02/2015
Date registered
3/03/2015
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a Pathogen Blood Test for patients with Lyme-like symptoms
Scientific title
Patients with Lyme-like symptoms are tested for presence of infectious agents including Borrelia, Rickettsia, Babesia, and fungal infections by combining microscopy and genetic DNA analysis
Secondary ID [1] 286196 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suspected Lyme Disease 294228 0
Neurological conditions 303143 0
Arthritis 303144 0
Condition category
Condition code
Infection 294547 294547 0 0
Studies of infection and infectious agents
Neurological 302590 302590 0 0
Neurodegenerative diseases
Musculoskeletal 302591 302591 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients presenting to the NIIM clinic with Lyme-like symptoms, including those with joint pain, chronic fatigue, and neurological conditions will be invited to undertake the Pathogen Blood test. The first part of the test involves a Pathogen screen by filtration of 10 ml of blood and microscopy.The second part of the test involves DNA extraction out of whole blood and PCR-DNA analysis of infectious agents, specifically Borrelia bacteria, Rickettsia, Babesia and fungal pathogens. To further identify the nature of the fungal infection, the PCR products are sequenced.
Intervention code [1] 291214 0
Diagnosis / Prognosis
Comparator / control treatment
Standard diagnostic test for Borrelia, including culturing of blood of the same patient and subsequent PCR analysis, using standardised methods by a pathology service.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294328 0
PCR-DNA analysis test results: Presence or absence of Borrelia bacteria
Timepoint [1] 294328 0
baseline
Primary outcome [2] 302007 0
PCR-DNA analysis test results: Presence or absence of fungal elements
Timepoint [2] 302007 0
baseline
Primary outcome [3] 302008 0
PCR-DNA analysis test results: Presence or absence of Rickettsia bacteria
Timepoint [3] 302008 0
baseline
Secondary outcome [1] 313052 0
This is a composite secondary outcome. Visual presence or absence of bacteria, fungal elements or other infectious agents after filtration using cytopathological and microbiological criteria.
Timepoint [1] 313052 0
baseline

Eligibility
Key inclusion criteria
Patients presenting with Lyme-like symptoms (including joint pain, chronic fatigue, neurological problems), as suggested by a treating medical practitioner
May or may not know if bitten by a tick
May or may not developed bull's eye rash
May or may not have been diagnosed with Borrelia infection previously
Minimum age
3 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not able to provide consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be invited to participate in this study via the NIIM website, NIIM doctors, and other clinics and institutes interested in the Pathogen Blood Test. Patients who cannot come to the clinic in person or don't live locally, can order a blood test kit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive & qualitative analysis, correlation of novel diagnostic method and standard diagnostic method, correlation of cytopathological findings and PCR-DNA analysis.
This is an exploratory study. The suggested sample size is based on clinical practice patients enquiring about treatment for Lyme-like illness.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2015
Actual
31/03/2015
Date of last participant enrolment
Anticipated
30/12/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
420
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9244 0
3122 - Hawthorn West

Funding & Sponsors
Funding source category [1] 290769 0
Self funded/Unfunded
Name [1] 290769 0
Patients coming to the National Institute of Integrative Medicine
Country [1] 290769 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Institute of Integrative Medicine
Address
21 Burwood Rd, Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 289453 0
None
Name [1] 289453 0
Address [1] 289453 0
Country [1] 289453 0
Other collaborator category [1] 278354 0
None
Name [1] 278354 0
none
Address [1] 278354 0
none
Country [1] 278354 0
Other collaborator category [2] 278355 0
Individual
Name [2] 278355 0
Prof Avni Sali
National Institute of Integrative Medicine
Address [2] 278355 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Country [2] 278355 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292400 0
NIIM HREC
Ethics committee address [1] 292400 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Ethics committee country [1] 292400 0
Australia
Date submitted for ethics approval [1] 292400 0
10/02/2015
Approval date [1] 292400 0
16/02/2015
Ethics approval number [1] 292400 0
0022N-2015

Summary
Brief summary
For chronic illnesses such as Lyme-like Illness, Chronic Fatigue Syndrome, and Chronic Pain, differential diagnosis is regularly made on the basis of signs and symptoms rather than specific medical tests. This means that the cause of such illnesses often remains unidentified.

For Lyme Disease or Borreliosis, standard diagnostic testing typically involves indirect serology testing of antibodies made by the body in response to an infection or foreign agent. However, such indirect forms of testing can be problematic as antibodies produced in response to infection by a specific foreign agent can bind not only with antigens of the specific foreign agent, but also to antigens of other infectious agents. For instance, cross-reacting antibodies can be produced in response to both Borrelia burgdorferi bacteria (causative agent for Lyme disease) and certain types of viruses or other infections, potentially causing diagnostic confusion in interpreting the results of serological testing (such as Western blot technique). “Many diseases have been reported to cause significant cross-reactivity in IgM and/or IgG assays. Among such diseases are autoimmune disorders, Epstein-Barr virus infection, bacterial endocarditis, syphilis, other spirochetal infections, and Helicobacter pylori infection.” [Ref: Reed, Kurt D. "Laboratory testing for Lyme disease: possibilities and practicalities." Journal of clinical microbiology 40.2 (2002): 319-324.]
Moreover, antibodies may circulate in the body long after an acute infection (for example, around ten to twenty years after a Borrelia infection), further adding to the diagnostic confusion.
This observational study aims to identifying DNA containing non-human cells or pathogens present in a patient’s blood sample. The study combines blood filtration, microscopy and PCR-DNA genetic analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55022 0
Dr Karin Ried
Address 55022 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 55022 0
Australia
Phone 55022 0
+61 3 9912 9545
Fax 55022 0
Email 55022 0
[email protected]
Contact person for public queries
Name 55023 0
Karin Ried
Address 55023 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 55023 0
Australia
Phone 55023 0
+61 3 9912 9545
Fax 55023 0
Email 55023 0
[email protected]
Contact person for scientific queries
Name 55024 0
Karin Ried
Address 55024 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country 55024 0
Australia
Phone 55024 0
+61 3 9912 9545
Fax 55024 0
Email 55024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1917Informed consent form    Pathogen Test Request Form & Informed Consent Form 367991-(Uploaded-18-04-2019-17-17-49)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.