Urinary Tract InfectionsNCT03190421
Expanded Quantitative Urinary Culture (EQUC) vs Standard Culture (SUC) Techniques in the Clinical Care
A study testing Expanded Urinary Culture and Standard Urine Culture (SUC) in people with Urinary Tract Infections, run by Loyola University at 1 site in United States.
Trial summary
This purpose of this study is to see if expanded urine culture techniques used in the laboratory improve the clinical care of women over standard urine culture techniques. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Expanded Urinary Culture and Standard Urine Culture (SUC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 30 Apr 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A "yes" answer to the screening question "do you feel you have a UTI"?
- Non-pregnant women ages 18 years or older
- Agreement to respond to a text or email question 7-10 days after treatment plan for their UTI (note: the treatment plan may include "no treatment").
Who cannot join
- Women currently on antibiotics
- Patients who cannot communicate or read in English
- Patients under the age of 18
- Pregnant patients
- Women with an indwelling catheter and intermittent self-catheterization
- Men
Show all 9Show fewer
- Urine obtained via the "clean catch method" (i.e. voided urine)
- Women who refuse to be catheterized
- Women who cannot or will not agree to respond to an email or text message 7-10 days after treatment plan is initiated.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: The Use of Expanded Quantitative Urinary Culture (EQUC) Versus Standard Culture (SUC) Techniques in the Clinical Care of Women With Symptoms of Urinary Tract Infections.
This purpose of this study is to see if expanded urine culture techniques used in the laboratory improve the clinical care of women over standard urine culture techniques.
Read the detailed description
The investigators request permission to recruit 225 women who respond "yes" to the question "do you feel you have a urinary tract infection". All participants will provide baseline urine specimens obtained by transurethral catheter (to avoid vulvo-vaginal contamination) and will complete a UTISA questionnaire to assess their current urinary tract symptoms. Participants will be randomized to the SUC treatment algorithm or the EQUC treatment algorithm. Treating physicians will receive either the SUC results or the EQUC results from the clinical laboratory and the results will be part of their clinical record. Treating physicians will follow the Loyola FPMRS treatment algorithm. Women in the study will also give consent for us to contact them using email, text messaging or phone call within 7-10 days after "treatment plan" has been implemented. The treatment plan options will include no treatment if the culture results show no pathogenic bacteria. All participants will be queried 7-10 days after their treatment plan (by email or text) "do you feel you continue to have a urinary tract infection". Women who respond "yes' will be asked to return for a second urine specimen which is our standard protocol. The second urine specimen will be analyzed using EQUC culture techniques only. Again, a treatment plan will be developed by the attending physician and the patient participant will be queried 7-10 days after the plan is implemented.
- Conditions
- Urinary Tract Infections
- Being tested
- Expanded Urinary Culture, Standard Urine Culture (SUC)
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Urinary CultureDiagnostic test
involves the inoculation of 100X (0.1mL) more urine onto diverse types of media (BAP, chocolate agar, colistin and nalidixic acid (CNA) agar, CDC anaerobe 5% BAP) with incubation in more environments and temperatures (5% CO2 at 35°C for 48 h, aerobic conditions at 35°C and 30°C for 48 h, Campy gas mixture (5% O2, 10% CO2, 85% N) or anaerobic conditions at 35°C for 48 h). The level of detection for EQUC is 10 CFU/mL, represented by 1 colony of growth on any of the plates. EQUC is designed to isolate a broad array of Gram-negative and Gram-positive bacteria, including anaerobes and fastidious bacteria that grow slowly.
Standard Urine Culture (SUC)Diagnostic test
involves inoculation of 0.001 mL of urine onto 5% sheep blood agar plate (BAP) and MacConkey agar plate with the plates being incubated aerobically at 35°C for 24 h. Thus, the level of detection for standard culture is 103 CFU/mL, represented by 1 colony of growth on either plate. Standard culture is designed specifically to grow Gram-negative rods, especially UPEC.
| Study group | Role | What they receive |
|---|---|---|
| Expanded Urinary Culture (EQUC) | Experimental | Participants in this arm will receive the expanded urine culture Receives: Diagnostic Test: Expanded Urinary Culture |
| Standard Urine Culture (SUC) | Active comparator | Participants in this arm will receive the standard urine culture Receives: Diagnostic Test: Standard Urine Culture (SUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare UTI symptom resolution rates in women with symptoms of UTI who are treated based on EQUC versus SUC results.
Using the FPMRS treatment algorithms (see appendix I \& II Standard Urine Culture Treatment and Expanded Urine Culture Treatment Algorithms), attending physicians will treat participants based on their randomization to EQUC versus SUC. Following a 3-5 day standard course of treatment (which may include no antibiotics if the culture is negative), participants will be queried 7-10 days "do you continue to have UTI symptoms". Women who report "no" will be categorized as successful treatment, women who respond "yes" will be categorized as treatment failures.
Measured: 4 weeks
Secondary outcomes (2)
Revise the EQUC treatment algorithm.
The EQUC treatment algorithm was based on known uropathogens that we had previously identified as most likely to be symptomatic. During the course of this work we may identify other pathogens that are present and causing symptoms. These organisms will be identified and added to the treatment algorithm. This interim analysis is planned and was part of the statistical calculations to determine sample size.
Measured: 6 months
Identify the symptom profile associated with specific organisms.
Using the UTISA questionnaire, we will perform a symptoms association study with specific bacteria.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start15 Jun 2017
- Primary completion30 Mar 2020
- Study completion30 Apr 2020
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 Urinary Tract InfectionsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Expanded Quantitative Urinary Culture (EQUC) versus Standard Culture (SUC) Techniques
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Mueller, Loyola University
- Investigators
- Elizabeth Mueller, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190421
- Sponsor's protocol ID
- 209545
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
KASS EH. Asymptomatic infections of the urinary tract. Trans Assoc Am Physicians. 1956;69:56-64. No abstract available.
PubMed 13380946Maskell R, Pead L, Allen J. The puzzle of "urethral syndrome": a possible answer? Lancet. 1979 May 19;1(8125):1058-9. doi: 10.1016/s0140-6736(79)92953-2.
PubMed 86778Yuan S, Cohen DB, Ravel J, Abdo Z, Forney LJ. Evaluation of methods for the extraction and purification of DNA from the human microbiome. PLoS One. 2012;7(3):e33865. doi: 10.1371/journal.pone.0033865. Epub 2012 Mar 23.
PubMed 22457796
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Expanded Quantitative Urinary Culture (EQUC) Versus Standard Culture (SUC) Techniques in the Clinical Care of Women With Symptoms of Urinary Tract Infections.
- ClinicalTrials.gov ID
- NCT03190421
- Acronym / sponsor ID
- 209545
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 16 Jun 2017 (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.
This purpose of this study is to see if expanded urine culture techniques used in the laboratory improve the clinical care of women over standard urine culture techniques.
Detailed description
The investigators request permission to recruit 225 women who respond "yes" to the question "do you feel you have a urinary tract infection". All participants will provide baseline urine specimens obtained by transurethral catheter (to avoid vulvo-vaginal contamination) and will complete a UTISA questionnaire to assess their current urinary tract symptoms. Participants will be randomized to the SUC treatment algorithm or the EQUC treatment algorithm. Treating physicians will receive either the SUC results or the EQUC results from the clinical laboratory and the results will be part of their clinical record. Treating physicians will follow the Loyola FPMRS treatment algorithm. Women in the study will also give consent for us to contact them using email, text messaging or phone call within 7-10 days after "treatment plan" has been implemented. The treatment plan options will include no treatment if the culture results show no pathogenic bacteria. All participants will be queried 7-10 days after their treatment plan (by email or text) "do you feel you continue to have a urinary tract infection". Women who respond "yes' will be asked to return for a second urine specimen which is our standard protocol. The second urine specimen will be analyzed using EQUC culture techniques only. Again, a treatment plan will be developed by the attending physician and the patient participant will be queried 7-10 days after the plan is implemented.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Expanded Quantitative Urinary Culture (EQUC) versus Standard Culture (SUC) Techniques
| Arm | Type | Receives |
|---|---|---|
| Expanded Urinary Culture (EQUC) | Experimental | Diagnostic Test: Expanded Urinary CultureParticipants in this arm will receive the expanded urine culture |
| Standard Urine Culture (SUC) | Active comparator | Diagnostic Test: Standard Urine Culture (SUC)Participants in this arm will receive the standard urine culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A "yes" answer to the screening question "do you feel you have a UTI"?
- Non-pregnant women ages 18 years or older
- Agreement to respond to a text or email question 7-10 days after treatment plan for their UTI (note: the treatment plan may include "no treatment").
Key exclusion criteria (9 listed)
- Women currently on antibiotics
- Patients who cannot communicate or read in English
- Patients under the age of 18
- Pregnant patients
- Women with an indwelling catheter and intermittent self-catheterization
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 |
|---|---|---|
| Expanded Urinary Cultureinvolves the inoculation of 100X (0.1mL) more urine onto diverse types of media (BAP, chocolate agar, colistin and nalidixic acid (CNA) agar, CDC anaerobe 5% BAP) with incubation in more environments and temperatures (5% CO2 at 35°C for 48 h, aerobic conditions at 35°C and 30°C for 48 h, Campy gas mixture (5% O2, 10% CO2, 85% N) or anaerobic conditions at 35°C for 48 h). The level of detection for EQUC is 10 CFU/mL, represented by 1 colony of growth on any of the plates. EQUC is designed to isolate a broad array of Gram-negative and Gram-positive bacteria, including anaerobes and fastidious bacteria that grow slowly. | Diagnostic test | Expanded Urinary Culture (EQUC) |
| Standard Urine Culture (SUC)involves inoculation of 0.001 mL of urine onto 5% sheep blood agar plate (BAP) and MacConkey agar plate with the plates being incubated aerobically at 35°C for 24 h. Thus, the level of detection for standard culture is 103 CFU/mL, represented by 1 colony of growth on either plate. Standard culture is designed specifically to grow Gram-negative rods, especially UPEC. | Diagnostic test | Standard Urine Culture (SUC) |
Primary outcome
Compare UTI symptom resolution rates in women with symptoms of UTI who are treated based on EQUC versus SUC results.
Time frame: 4 weeks
Using the FPMRS treatment algorithms (see appendix I \& II Standard Urine Culture Treatment and Expanded Urine Culture Treatment Algorithms), attending physicians will treat participants based on their randomization to EQUC versus SUC. Following a 3-5 day standard course of treatment (which may include no antibiotics if the culture is negative), participants will be queried 7-10 days "do you continue to have UTI symptoms". Women who report "no" will be categorized as successful treatment, women who respond "yes" will be categorized as treatment failures.
2 secondary outcomes
Revise the EQUC treatment algorithm.
Time frame: 6 months
Identify the symptom profile associated with specific organisms.
Time frame: 1 year
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 16 Jun 2020.
- Results publication: PubMed 13380946KASS EH. Asymptomatic infections of the urinary tract. Trans Assoc Am Physicians. 1956;69:56-64. No abstract available.
- Results publication: PubMed 86778Maskell R, Pead L, Allen J. The puzzle of "urethral syndrome": a possible answer? Lancet. 1979 May 19;1(8125):1058-9. doi: 10.1016/s0140-6736(79)92953-2.
- Results publication: PubMed 22457796Yuan S, Cohen DB, Ravel J, Abdo Z, Forney LJ. Evaluation of methods for the extraction and purification of DNA from the human microbiome. PLoS One. 2012;7(3):e33865. doi: 10.1371/journal.pone.0033865. Epub 2012 Mar 23.
- Individual participant dataSharing planned: No
Related trials for Urinary Tract Infections
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
RecruitingPhase 2
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection
Chronic Urinary Tract Infection
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, Stress Urinary Incontinence
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
Elizabeth Mueller, MD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded Urinary Culture and Standard Urine Culture (SUC) in people with Urinary Tract Infections, run by Loyola University 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 9 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 16 Jun 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?
Compare UTI symptom resolution rates in women with symptoms of UTI who are treated based on EQUC versus SUC results. (time frame: 4 weeks). 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 NCT03190421, 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 16 Jun 2020; AzTrials last refreshed its copy on 2 Nov 2026.