Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000070336
Ethics application status
Approved
Date submitted
10/04/2015
Date registered
13/01/2017
Date last updated
13/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antimicrobial Resistance Patterns of Paediatric Urinary Tract Infections in South Australia
Scientific title
Antimicrobial resistance patterns in urinary isolates for optimization of empirical treatment of paediatric urinary tract infections
Secondary ID [1] 286487 0
Nil
Universal Trial Number (UTN)
U1111-1169-1024
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric Urinary Tract Infections 294696 0
Condition category
Condition code
Renal and Urogenital 294989 294989 0 0
Other renal and urogenital disorders
Infection 301291 301291 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Urinary tract infection is a common bacterial infection in the paediatric population. It is an important cause of morbidity and mortality in children under 2 years of age. Increasing antibiotic resistance trends have important clinical implications for the empirical use of antibiotics. It is know that antimicrobial resistance vary according to geographic region. Knowledge of antimicrobial resistance patterns locally may aid clinicians in prescribing accurate empirical antibiotics treatment.

This is a retrospective observational study is to examine antimicrobial resistance patterns in paediatric urinary tract infections in a single centre over the period of 12 months (1st April 2013 to 31st March 2014). Antimicrobial resistance patterns of patients with renal tract abnormalities were compared to those patients with normal renal tracts.

All paediatric urine samples from 1st April 2013 to 31st March 2014 were reviewed. These samples were obtained from children who presented to the outpatient or emergency department; or who were admitted as inpatients. Urine samples that were collected by Paedibag (pediatric urine collection bag) and cottonball collection method were excluded. Cultures with mixed growth, and common contaminants were excluded. To prevent duplication, repeat samples within 30 days of first positive urine culture were excluded.
Intervention code [1] 291584 0
Not applicable
Comparator / control treatment
Comparison of antimicrobial resistance patterns in patients with renal tract abnormalities to patients with normal renal tracts
Control group
Active

Outcomes
Primary outcome [1] 294741 0
1. To determine antimicrobial resistance patterns in urine isolates in paediatric patients
0 to 18 years old in a single centre.

Data of urine samples submitted to the Microbiology laboratory for microscopy, culture
and susceptibility testing were extracted from laboratory information system. Susceptibility testing was performed using disc diffusion method. Semi quantitative urine culture using a calibrated loop was used to inoculate blood agar and CHROM agar. The significant pathogens were identified by standard biochemical identification methods. Susceptibility testing was conducted by disc diffusion according to EUCAST methodology.
Timepoint [1] 294741 0
Data of urine samples were extracted from laboratory information system for children under the age of 18 years between 1st April 2013 and 31st March 2014. These samples were obtained from children who presented to the outpatient or emergency department; or who were admitted as inpatients. To prevent duplication, repeat samples within 30 days of first positive urine culture were excluded.

As this is a retrospective review of laboratory results, the exact time of when the samples were processed cannot be accurately determined. The results of culture and sensitivities were generally finalized at 48 hours post receiving urine samples.

Primary outcome [2] 294742 0
2, To determine whether there is a difference in antibiotic resistance in urine isolates in patients with renal tract abnormalities

Children with proven renal tract abnormalities (RTA) were identified from radiology reports and discharge summaries on the hospital electronic medical database.The influence of the presence of RTA on antimicrobial resistance was analysed using statistical software.
Timepoint [2] 294742 0
Children who had renal tract abnormalities (RTA) reported on radiology reports and/or discharge summaries at any time prior to the commencement of the study were categorized in the positive for RTA group.

The urine samples were collected from children who presented to the to the outpatient or emergency department; or who were admitted as inpatients between 1st April 2013 to 31st March 2013. The timing of urine collection is different for every child, it may be on the first day of presentation to hospital (most Emergency Department cases) or after presentation (admitted or Outpatient cases).
Secondary outcome [1] 313979 0
3. To assess levels of bacteraemia in paediatric patients with confirmed UTI from ages 0-2yrs old by collating data of blood cultures and cerebrospinal fluid culture (if available)

Results of blood culture samples and cerebrospinal fluid samples (where available) were reviewed in children from ages 0 - 2 years who presented with UTI. Positive samples were defined as cultures positive with the same isolate as urine culture within 5 days of collection of urine sample.
Timepoint [1] 313979 0
Positive blood cultures were defined as a single blood culture positive with same isolate as urine culture within 5 days collection of urine sample. Positive cerebrospinal fluid was defined as a single cerebrospinal fluid culture positive with same isolate as urine culture within 5 days of positive urine culture.
Secondary outcome [2] 313980 0
4. To evaluate whether current empiric antibiotic guidelines for paediatric urinary tract infections are adequate and whether a new antibiotic guideline is required for high risk patients/younger patients

The hospital’s current paediatric antimicrobial guidelines for empirical treatment of paediatric UTI and results of antimicrobial resistance patterns were reviewed (to assess if recommendations made were compatible/supported by antimicrobial resistance results).



Timepoint [2] 313980 0
When antimicrobial resistance patterns were determined, recommendations based on these results were compared to current guidelines for empirical treatment of paediatric UTI.

Eligibility
Key inclusion criteria
1. Positive urine culture from patients ages 0 -18 years old.
2. Samples collected by suprapubic aspiration, catheterization and non-invasive collection sample (midstream) were include.
3. Only pure growth or predominantly pure growth samples were included.
4. Only the first positive urine sample of the encounter was included in the analysis to eliminate repetition.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Positive urine culture within 30 days of the same patient were excluded to avoid repeat.
2. Pedibag (paediatric urinary bag) and cottonball collected samples were excluded.
3. Samples with mixed growth and common contaminants were excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
The data was analysed using Stata v14.0 (StataCorp LP, College Station, Texas, USA). 7135 urine samples were reviewed and a total 642 positive urine samples meeting inclusion criteria were identified. This number is comparable to previous similar studies of paediatric UTI which were conducted overseas.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
1000
Accrual to date
Final
642
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3676 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 9505 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 291065 0
Hospital
Name [1] 291065 0
Women's & Children's Hospital
Country [1] 291065 0
Australia
Primary sponsor type
Individual
Name
Dr Su Ling Chua
Address
Women's & Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country
Australia
Secondary sponsor category [1] 289746 0
None
Name [1] 289746 0
None
Address [1] 289746 0
None
Country [1] 289746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292649 0
Women's & Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 292649 0
Women's & Children's Hospital,
72 King William Road, North Adelaide SA 5006
Ethics committee country [1] 292649 0
Australia
Date submitted for ethics approval [1] 292649 0
30/12/2014
Approval date [1] 292649 0
11/03/2015
Ethics approval number [1] 292649 0
HREC/15/WCHN/11

Summary
Brief summary
This study is aimed at collating and analysing data of paediatric urinary tract infections, identifying antibiotic resistance patterns in different groups of children by age, gender, presence of renal tract abnormalities. It will also assessed the level of bacteraemia in younger children. The data will be used to evaluate whether current empiric antibiotics guidelines are adequate and suitable for all groups of patients and whether there is a need for new guidelines for high risk patients and younger patients.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Attachments [1] 391 391 0 0
/AnzctrAttachments/368324-Ethics_Approval.pdf

Contacts
Principal investigator
Name 56354 0
Dr Su Ling Chua
Address 56354 0
Women's & Children's Hospital,
72 King William Road, North Adelaide SA 5006
Country 56354 0
Australia
Phone 56354 0
+61881617000
Fax 56354 0
Email 56354 0
[email protected]
Contact person for public queries
Name 56355 0
Su Ling Chua
Address 56355 0
Women's & Children's Hospital,
72 King William Road, North Adelaide SA 5006
Country 56355 0
Australia
Phone 56355 0
+61881617000
Fax 56355 0
Email 56355 0
[email protected]
Contact person for scientific queries
Name 56356 0
Su Ling Chua
Address 56356 0
Women's & Children's Hospital,
72 King William Road, North Adelaide SA 5006
Country 56356 0
Australia
Phone 56356 0
+61881617000
Fax 56356 0
Email 56356 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.