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Trial registered on ANZCTR


Registration number
ACTRN12616001076460
Ethics application status
Approved
Date submitted
2/06/2016
Date registered
10/08/2016
Date last updated
24/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is there a relationship between mannose binding protein deficiency and infections in people with autoimmune inflammatory conditions?
Scientific title
Frequent UrInary Tract Sepsis in Auto-Immune, Lupus-like And other immune-inflammatory Diseases: Is there a correlation with mannose binding lectin deficiency?
Secondary ID [1] 289016 0
none known
Universal Trial Number (UTN)
Trial acronym
FRUIT SALAD project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Auto immune conditions 298430 0
Mannose binding lectin deficiency 298431 0
Urinary tract infection 298432 0
Condition category
Condition code
Inflammatory and Immune System 298529 298529 0 0
Autoimmune diseases
Infection 298530 298530 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
341 people (from a private practice clinic) with diagnosed autoimmune inflammatory disease that have had mannose binding lectin levels recorded will be posted a questionnaire to determine the number and frequency of infection over the past 7 years. Those who fail to return the questionnaire will receive a follow up phone call 4 weeks later.
Intervention code [1] 294501 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298019 0
Level of mannose binding lectin was measured using the MBL Oligomer ELISA kit to determine the concentration in human serum.
Timepoint [1] 298019 0
Baseline
Primary outcome [2] 298020 0
Number of urinary tract infections verified by urine sample and laboratory testing as recorded in patient notes.
Timepoint [2] 298020 0
Completed at single timepoint in relation to previous 7 years
Secondary outcome [1] 322911 0
Details concerning the number of infections were obtained by conducting a retrospective audit of hospital admission records and a state-wide government Health database, for all participants. That an infection had occurred, it’s nature and the outcome of treatment was recorded.
Timepoint [1] 322911 0
Completed at single timepoint in relation to previous 7 years

Eligibility
Key inclusion criteria
Physician diagnosed auto-immune disease such as:
Rheumatoid Arthritis
Systemic Lupus Erythematous
Psoriatic arthritis
Ankylosing Spondylitis
Pre-determined MBL concentrations (determined for other reasons)

Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Males
Patients without diagnosed auto-immune disease
Patients without MBL concentrations

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
This is an explorative study. We have 341 case records of females with autoimmune conditions. We will examine these to determine if there is a relationship between urinary tract infections and mannose binding lectin deficiencies. Since there is little published data on this relationship, we are unable to perform a power calculation based on prior research findings.
Descriptive statistics will be presented as means and standard deviations for continuous variables and as percentages for categorical variables. Statistical analysis will be carried out using simple parametric tests as well as Poisson regression models (to investigate factors related to the incidence of Serious Infections) and Logistic regression models (to investigate factors related to multiple serious infections). Rate ratios and 95% confidence intervals will be reported.
t tests - Correlation: Point biserial model

Analysis: Post hoc: Compute achieved power
Input: Tail(s) = Two
Effect size |p| = 0.3
a err prob = 0.05
Total sample size = 341
Output: Noncentrality parameter d = 5.8073466
Critical t = 1.9669865
Df = 339
Power (1-beta err prob) = 0.9999362


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 293384 0
Commercial sector/Industry
Name [1] 293384 0
ArthroCare
Address [1] 293384 0
19A Guildford Road
Mount Lawley
WA, 6050
Country [1] 293384 0
Australia
Primary sponsor type
Individual
Name
Sophie Coleman
Address
ArthroCare
19A Guildford Road
Mount Lawley
WA, 6050
Country
Australia
Secondary sponsor category [1] 292203 0
Individual
Name [1] 292203 0
Graeme Carroll
Address [1] 292203 0
Arthrocare
19A Guildford Road
Mount Lawley
WA 6050
Country [1] 292203 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294841 0
University of Notre Dame
Ethics committee address [1] 294841 0
32 Mouat St, Fremantle WA 6959
Ethics committee country [1] 294841 0
Australia
Date submitted for ethics approval [1] 294841 0
22/04/2016
Approval date [1] 294841 0
12/05/2016
Ethics approval number [1] 294841 0
016062F

Summary
Brief summary
Project Aim:
To determine whether there is a relationship between low Mannose Binding Lectin concentrations (a protein produced in the liver, that acts in the recognition of disease causing pathogens) and frequent Urinary Tract Infections (UTIs) in patients who have an autoimmune disease.
Hypothesis:
MBL deficiency predisposes to frequent UTIs in female patients with auto-immune diseases
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65210 0
Dr Graeme Carroll
Address 65210 0
Arthrocare
19 Guildford Road, Mount Lawley WA 6050
Country 65210 0
Australia
Phone 65210 0
+61 8 9271 6306
Fax 65210 0
+61 8 9370 3957
Email 65210 0
gjcarrollmd@gmail.com
Contact person for public queries
Name 65211 0
Dr Graeme Carroll
Address 65211 0
Arthrocare
19A Guildford Road, Mount Lawley WA 6050
Country 65211 0
Australia
Phone 65211 0
+61 8 9271 6306
Fax 65211 0
+61 8 9370 3957
Email 65211 0
gjcarrollmd@gmail.com
Contact person for scientific queries
Name 65212 0
Dr Graeme Carroll
Address 65212 0
Arthrocare
19A Guildford Road, Mount Lawley WA 6050
Country 65212 0
Australia
Phone 65212 0
+61 8 9271 6306
Fax 65212 0
+61 8 9370 3957
Email 65212 0
gjcarrollmd@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary