Urine ContaminationNCT03933436
EPIC: Effect of Povidone Iodine Periurethral Cleansing on Level of Contamination With Clean Catch
A study testing Iodine swabs. and Saline flush. in people with Urine Contamination, run by Travis Callahan at 1 site in United States.
Trial summary
The primary aim of this study is to see if the use of an antiseptic preparation (povidone iodine) versus cold normal saline, will decrease rates of urine contamination during the non-invasive Quick Wee (QW) collection of pediatric urine. Read more about this study
- Who is it for?
- Ages 28 days to 12 months
- Conditions the study is for
- Urine Contamination
- What is being tested?
- Iodine swabs. and Saline flush.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 28 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DoD children aged one month (28 days) to 12 months (365 days) (if the child was born less than 36 weeks gestation, age will be corrected)
- Precontinent (meaning that the child is unable to void on command)
- Treating clinician has determined that the child requires urine sample collection for course of treatment.
Who cannot join
- If the treating clinician has determined that there is a need for immediate treatment and urine sample collection via invasive method, any type of anatomical or neurologic condition that will affect the ability to void or sensation of the suprapubic area.
- Children with past hypersensitivity reactions to iodine swabs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Military Medical Center
Las Vegas, Nevada, 89191
About this study
Official title: EPIC: Effect of Povidone Iodine Periurethral Cleansing on Level of Contamination With Clean Catch: A Randomized Control Trial
The primary aim of this study is to see if the use of an antiseptic preparation (povidone iodine) versus cold normal saline, will decrease rates of urine contamination during the non-invasive Quick Wee (QW) collection of pediatric urine.
Read the detailed description
Urinary tract infections (UTI) are common acute illnesses among pediatric patients, accounting for 5-7% of emergency department visits in the under two-year-old population. However, obtaining urine samples from the precontinent patient can be difficult. There is an ongoing debate regarding which noninvasive method for urine specimen collection is best for this population. The main argument against clean catch is the high rate of contamination compared to invasive collection and reliability.
There are many methods of noninvasive urine collection. These methods are preferred as they are fairly well tolerated by patients, less distressing to parents, cost effective, and require less technical expertise. In the past; these methods have been dismissed due to their high rates of contamination, time to void and also effectiveness. The National Institute of Health and Clinical Excellence (NICE, UK) recommends a clean-catch urine (CCU) be the first attempt at obtaining a urine specimen from children suspected of having UTI. This means placing the urine specimen collection container into the urine mid-stream once the child has begun to void to avoid contamination. Conversely, the American Academy of Pediatrics recommends clean catch urine for screening and a catheter specimen urine collection or suprapubic aspiration for definitive diagnosis. Both of these invasive techniques produce quick urine samples with low rates of contamination; however they can be painful and distressing to both the patient and parent.
The Quick-Wee method for noninvasive urine collection has been evaluated in a one randomized controlled trial and has been shown to significantly increase the five minute voiding success rate for CC urine collection; 31%, n= 174. However a past study demonstrated contamination rate of 27%, n=174. No study has directly evaluated the use of antiseptic solution in the evaluation of the QW rate of contamination in pediatric patients. The purpose of this study is to see whether the use of povidone iodine swabs prior to the QW method will decrease the rate of contamination. A decrease of the rate of contamination would strengthen the validity of this simple CCU method. Also using the this method for the collection method in both the experimental and control groups will further evaluated the five min void success rate.
The investigators chose to use iodine as the prepping agent because it is currently the standard cleaning solution used for adult and pediatric patients. It is readily available, inexpensive and has been shown to be less caustic then other prepping agents.
- Conditions
- Urine Contamination
- Being tested
- Iodine swabs., Saline flush.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine swabs.Other
Children will then have their periurethral region gently cleansed for ten seconds with iodine swabs.
Saline flush.Other
Children will then have their periurethral region gently cleansed for ten seconds with saline flush.
| Study group | Role | What they receive |
|---|---|---|
| Iodine | Experimental | Iodine swabs. Receives: Other: Iodine swabs. |
| Normal Saline | Active comparator | Saline flush. Receives: Other: Saline flush. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant samples indicating urine contamination
Binary yes/no outcome of detection of microbial markers to determine level of contamination
Measured: 24 to 48 hours
Secondary outcomes (1)
Number of participants who void urine
Binary yes/no outcome of voiding urine
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 May 2019
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urine ContaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Travis Callahan
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Travis Callahan, Mike O'Callaghan Military Hospital
- Investigators
- Paul F Crawford, MD, Study director, Mike O'Callaghan Military Medical Center, 99MDG, US Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933436
- Sponsor's protocol ID
- FWH20190009H
- Status last verified
- May 2020
- First submitted
- 23 Apr 2019
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaw KN, Gorelick M, McGowan KL, Yakscoe NM, Schwartz JS. Prevalence of urinary tract infection in febrile young children in the emergency department. Pediatrics. 1998 Aug;102(2):e16. doi: 10.1542/peds.102.2.e16.
PubMed 9685461National Collaborating Centre for Women's and Children's Health (UK). Urinary Tract Infection in Children: Diagnosis, Treatment and Long-term Management. London: RCOG Press; 2007 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK50606/
PubMed 21290637Practice parameter: the diagnosis, treatment, and evaluation of the initial urinary tract infection in febrile infants and young children. American Academy of Pediatrics. Committee on Quality Improvement. Subcommittee on Urinary Tract Infection. Pediatrics. 1999 Apr;103(4 Pt 1):843-52. doi: 10.1542/peds.103.4.843.
PubMed 10103321
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPIC: Effect of Povidone Iodine Periurethral Cleansing on Level of Contamination With Clean Catch: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03933436
- Acronym / sponsor ID
- FWH20190009H
- Conditions
- Urine Contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Travis CallahanUS federal agency
- Study start
- 1 May 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to see if the use of an antiseptic preparation (povidone iodine) versus cold normal saline, will decrease rates of urine contamination during the non-invasive Quick Wee (QW) collection of pediatric urine.
Detailed description
Urinary tract infections (UTI) are common acute illnesses among pediatric patients, accounting for 5-7% of emergency department visits in the under two-year-old population. However, obtaining urine samples from the precontinent patient can be difficult. There is an ongoing debate regarding which noninvasive method for urine specimen collection is best for this population. The main argument against clean catch is the high rate of contamination compared to invasive collection and reliability.
There are many methods of noninvasive urine collection. These methods are preferred as they are fairly well tolerated by patients, less distressing to parents, cost effective, and require less technical expertise. In the past; these methods have been dismissed due to their high rates of contamination, time to void and also effectiveness. The National Institute of Health and Clinical Excellence (NICE, UK) recommends a clean-catch urine (CCU) be the first attempt at obtaining a urine specimen from children suspected of having UTI. This means placing the urine specimen collection container into the urine mid-stream once the child has begun to void to avoid contamination. Conversely, the American Academy of Pediatrics recommends clean catch urine for screening and a catheter specimen urine collection or suprapubic aspiration for definitive diagnosis. Both of these invasive techniques produce quick urine samples with low rates of contamination; however they can be painful and distressing to both the patient and parent.
The Quick-Wee method for noninvasive urine collection has been evaluated in a one randomized controlled trial and has been shown to significantly increase the five minute voiding success rate for CC urine collection; 31%, n= 174. However a past study demonstrated contamination rate of 27%, n=174. No study has directly evaluated the use of antiseptic solution in the evaluation of the QW rate of contamination in pediatric patients. The purpose of this study is to see whether the use of povidone iodine swabs prior to the QW method will decrease the rate of contamination. A decrease of the rate of contamination would strengthen the validity of this simple CCU method. Also using the this method for the collection method in both the experimental and control groups will further evaluated the five min void success rate.
The investigators chose to use iodine as the prepping agent because it is currently the standard cleaning solution used for adult and pediatric patients. It is readily available, inexpensive and has been shown to be less caustic then other prepping agents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodine | Experimental | Other: Iodine swabs.Iodine swabs. |
| Normal Saline | Active comparator | Other: Saline flush.Saline flush. |
Who may qualify
- Ages
- 28 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- DoD children aged one month (28 days) to 12 months (365 days) (if the child was born less than 36 weeks gestation, age will be corrected)
- Precontinent (meaning that the child is unable to void on command)
- Treating clinician has determined that the child requires urine sample collection for course of treatment.
Key exclusion criteria (2 listed)
- If the treating clinician has determined that there is a need for immediate treatment and urine sample collection via invasive method, any type of anatomical or neurologic condition that will affect the ability to void or sensation of the suprapubic area.
- Children with past hypersensitivity reactions to iodine swabs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine swabs.Children will then have their periurethral region gently cleansed for ten seconds with iodine swabs. | Other | Iodine |
| Saline flush.Children will then have their periurethral region gently cleansed for ten seconds with saline flush. | Other | Normal Saline |
Primary outcome
Number of participant samples indicating urine contamination
Time frame: 24 to 48 hours
Binary yes/no outcome of detection of microbial markers to determine level of contamination
1 secondary outcome
Number of participants who void urine
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Background: PubMed 9685461Shaw KN, Gorelick M, McGowan KL, Yakscoe NM, Schwartz JS. Prevalence of urinary tract infection in febrile young children in the emergency department. Pediatrics. 1998 Aug;102(2):e16. doi: 10.1542/peds.102.2.e16.
- Background: PubMed 21290637National Collaborating Centre for Women's and Children's Health (UK). Urinary Tract Infection in Children: Diagnosis, Treatment and Long-term Management. London: RCOG Press; 2007 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK50606/
- Background: PubMed 10103321Practice parameter: the diagnosis, treatment, and evaluation of the initial urinary tract infection in febrile infants and young children. American Academy of Pediatrics. Committee on Quality Improvement. Subcommittee on Urinary Tract Infection. Pediatrics. 1999 Apr;103(4 Pt 1):843-52. doi: 10.1542/peds.103.4.843.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F Crawford, MD study director
Mike O'Callaghan Military Medical Center, 99MDG, US Air Force
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine swabs. and Saline flush. in people with Urine Contamination, run by Travis Callahan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participant samples indicating urine contamination (time frame: 24 to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933436, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.