Urinary Tract InfectionPhase 4STOPP UTINCT01450800
Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI)
A Phase 4 study testing Nitrofurantoin in people with Urinary Tract Infection, run by Duke University at 1 site in United States.
Trial summary
This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Nitrofurantoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing urogynecologic surgery
- Receive postoperative catheterization
Who cannot join
- Age less than 21 years old
- Pregnancy
- Allergy, contraindication or intolerance to Nitrofurantoin
- Do not speak English
- Dependent on trans-urethral catheter to accomplish voiding preoperatively
- Undergoing interstim device placement, urethral diverticulum surgery or fistula surgery
- Sustain intraoperative urinary tract injury requiring postoperative catheterization
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery
This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.
Read the detailed description
Study Population Participants will be recruited from all patients who are planning to undergo gynecologic surgery by an attending surgeon in the Division of Urogynecology at Duke University Medical Center (DUMC). After enrollment and randomization, the participants will take the study drug once daily to start on post-operative day one and continue until the participant has stopped catheterizing for up to one week after surgery. The participant will also complete a daily diary for one week after surgery to record any catheterization and any study drug or additional antibiotic medication taken. We will then follow patients for a total of three weeks after surgery to monitor for treatment for UTI. At three weeks after surgery the observation period for the participant is complete.
Sample Size Under the assumption of 80% power and an alpha error of 0.05, we would need 156 subjects to demonstrate a 66% reduction in risk of UTI (i.e. from 28% to 10%) in those undergoing prophylactic antibiotic treatment. Therefore, we aim to recruit a total of 175 participants to account for participant dropout.
Study Definitions For our study purposes, post-operative catheterization will be defined to include patients who are hospitalized post-operatively with an indwelling Foley catheter as well as patients discharged with either intermittent self-catheterization (ISC) or indwelling Foley catheter. The decision to catheterize will be determined by type of surgical procedure, need for inpatient stay and void trial results. Void trials will be conducted as follows: the bladder is backfilled with 300cc normal saline, the catheter is removed and the patient is prompted to void immediately and, after voiding is complete, a (PVR) post-void residual volume is measured. The patient passes the void trial if she voids over 200cc in total volume or if her PVR is less than 100cc.
Our primary outcome of treatment for UTI within the first three weeks after surgery is to be defined clinically. A patient will be considered to have received treatment for UTI if she receives any antibiotic therapy for clinically suspected or culture-proven urinary tract infection (i.e. empirically given upon development of urinary symptoms or prescribed based on urinalysis or urine culture results) within the first three weeks after surgery.
Data Collection Demographic characteristics, operative data and post-operative data will be collected. Prior to discharge after surgery all patients will undergo a void trial per standard procedure unless they receive an indwelling Foley catheter for overnight hospitalization. Post-operatively all subjects will be given a catheterization diary to record days of catheterization and days of antibiotic therapy. All subjects will be instructed to call our clinical office to report any urinary complaints and/or treatment for UTI. Information will be collected from electronic medical records regarding any office visits, urine cultures performed or treatment for UTI during this post-operative period. Data will be entered into a de-identified study database for analysis by the PI and study coordinator who will be blinded to participant randomization.
Subject Randomization and Blinding Study participants will be randomized to prophylactic treatment versus no treatment via a computerized randomization scheme by the IDS at the time of enrollment. Patients will be blinded to treatment by the utilization of placebo tablets.
Adverse Events Nitrofurantoin is FDA approved for the treatment of UTI. We will be using a prophylactic dose and will monitor for any adverse events. Adverse events will be reported per protocol. A safety monitoring designee will perform reviews on a designated basis throughout the study.
Study Costs There will be no additional cost to the patient for their participation in this study. No additional laboratory testing will be performed as a result of participation.
- Conditions
- Urinary Tract Infection
- Being tested
- Nitrofurantoin, Placebo
- Keywords
- urinary tract infection, gynecologic surgery, post-operative complications, nitrofurantoin
- 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.
NitrofurantoinDrug
Also called Macrobid, Macrodantin
Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively
PlaceboDrug
Also called Placebo medication, Inactive medication
Participants randomized to placebo will be instructed to take placebo one tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
| Study group | Role | What they receive |
|---|---|---|
| Nitrofurantoin | Active comparator | Nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization Receives: Drug: Nitrofurantoin |
| Placebo | Placebo comparator | Placebo drug 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Tract Infections
The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.
Measured: three weeks post-operative
Secondary outcomes (7)
Other Risk Factors for UTI
We examined risk of UTI as related to vaginal estrogen therapy
Measured: 3 weeks following surgery
Other Risk Factors for UTI
We examined risk of UTI as related to history of recurrent UTIs
Measured: 3 weeks following surgery
Other Risk Factors for UTI
We examined risk of UTI as related to preoperative UTI treatment
Measured: 3 weeks following surgery
Other Risk Factors for UTI
We examined risk of UTI as related to Creatinine Clearance
Measured: 3 weeks following surgery
Other Risk Factors for UTI
We examined risk of UTI as related to sling as part of surgery
Measured: 3 weeks following surgery
Other Risk Factors for UTI
We examined risk of UTI as related to total postoperative catheter days
Measured: 3 weeks following surgery
Other Risk Factors for UTI
We examined risk of UTI as related to postoperative catheter type
Measured: 3 weeks following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy Amundsen, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450800
- Sponsor's protocol ID
- Pro00025269
- Other IDs
- 3913577
- Acronym
- STOPP UTI
- Status last verified
- Dec 2016
- First submitted
- 10 Oct 2011
- Last updated
- 13 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Brown JS, Grady D, Ouslander JG, Herzog AR, Varner RE, Posner SF. Prevalence of urinary incontinence and associated risk factors in postmenopausal women. Heart & Estrogen/Progestin Replacement Study (HERS) Research Group. Obstet Gynecol. 1999 Jul;94(1):66-70. doi: 10.1016/s0029-7844(99)00263-x.
PubMed 10389720Hannestad YS, Rortveit G, Sandvik H, Hunskaar S; Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol. 2000 Nov;53(11):1150-7. doi: 10.1016/s0895-4356(00)00232-8.
PubMed 11106889Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
PubMed 17049716Thomas TM, Plymat KR, Blannin J, Meade TW. Prevalence of urinary incontinence. Br Med J. 1980 Nov 8;281(6250):1243-5. doi: 10.1136/bmj.281.6250.1243.
PubMed 7427654Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
PubMed 19935030Levin I, Groutz A, Gold R, Pauzner D, Lessing JB, Gordon D. Surgical complications and medium-term outcome results of tension-free vaginal tape: a prospective study of 313 consecutive patients. Neurourol Urodyn. 2004;23(1):7-9. doi: 10.1002/nau.10164.
PubMed 14694449Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8. doi: 10.1007/s001920170003.
PubMed 11450979Falagas ME, Athanasiou S, Iavazzo C, Tokas T, Antsaklis A. Urinary tract infections after pelvic floor gynecological surgery: prevalence and effect of antimicrobial prophylaxis. A systematic review. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1165-72. doi: 10.1007/s00192-008-0584-0. Epub 2008 Apr 10.
PubMed 18401538Sutkin G, Lowder JL, Smith KJ. Prophylactic antibiotics to prevent urinary tract infection during clean intermittent self-catheterization (CISC) for management of voiding dysfunction after prolapse and incontinence surgery: a decision analysis. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Aug;20(8):933-8. doi: 10.1007/s00192-009-0885-y. Epub 2009 Apr 10.
PubMed 19582384Macy E, Poon K-Y T. Self-reported antibiotic allergy incidence and prevalence: age and sex effects. Am J Med. 2009 Aug;122(8):778.e1-7. doi: 10.1016/j.amjmed.2009.01.034.
PubMed 19635279Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024.
PubMed 24463669
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery
- ClinicalTrials.gov ID
- NCT01450800
- Acronym / sponsor ID
- STOPP UTI / Pro00025269
- Conditions
- Urinary Tract Infection
- Keywords
- urinary tract infection, gynecologic surgery, post-operative complications, nitrofurantoin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Posted 1 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.
Detailed description
Study Population Participants will be recruited from all patients who are planning to undergo gynecologic surgery by an attending surgeon in the Division of Urogynecology at Duke University Medical Center (DUMC). After enrollment and randomization, the participants will take the study drug once daily to start on post-operative day one and continue until the participant has stopped catheterizing for up to one week after surgery. The participant will also complete a daily diary for one week after surgery to record any catheterization and any study drug or additional antibiotic medication taken. We will then follow patients for a total of three weeks after surgery to monitor for treatment for UTI. At three weeks after surgery the observation period for the participant is complete.
Sample Size Under the assumption of 80% power and an alpha error of 0.05, we would need 156 subjects to demonstrate a 66% reduction in risk of UTI (i.e. from 28% to 10%) in those undergoing prophylactic antibiotic treatment. Therefore, we aim to recruit a total of 175 participants to account for participant dropout.
Study Definitions For our study purposes, post-operative catheterization will be defined to include patients who are hospitalized post-operatively with an indwelling Foley catheter as well as patients discharged with either intermittent self-catheterization (ISC) or indwelling Foley catheter. The decision to catheterize will be determined by type of surgical procedure, need for inpatient stay and void trial results. Void trials will be conducted as follows: the bladder is backfilled with 300cc normal saline, the catheter is removed and the patient is prompted to void immediately and, after voiding is complete, a (PVR) post-void residual volume is measured. The patient passes the void trial if she voids over 200cc in total volume or if her PVR is less than 100cc.
Our primary outcome of treatment for UTI within the first three weeks after surgery is to be defined clinically. A patient will be considered to have received treatment for UTI if she receives any antibiotic therapy for clinically suspected or culture-proven urinary tract infection (i.e. empirically given upon development of urinary symptoms or prescribed based on urinalysis or urine culture results) within the first three weeks after surgery.
Data Collection Demographic characteristics, operative data and post-operative data will be collected. Prior to discharge after surgery all patients will undergo a void trial per standard procedure unless they receive an indwelling Foley catheter for overnight hospitalization. Post-operatively all subjects will be given a catheterization diary to record days of catheterization and days of antibiotic therapy. All subjects will be instructed to call our clinical office to report any urinary complaints and/or treatment for UTI. Information will be collected from electronic medical records regarding any office visits, urine cultures performed or treatment for UTI during this post-operative period. Data will be entered into a de-identified study database for analysis by the PI and study coordinator who will be blinded to participant randomization.
Subject Randomization and Blinding Study participants will be randomized to prophylactic treatment versus no treatment via a computerized randomization scheme by the IDS at the time of enrollment. Patients will be blinded to treatment by the utilization of placebo tablets.
Adverse Events Nitrofurantoin is FDA approved for the treatment of UTI. We will be using a prophylactic dose and will monitor for any adverse events. Adverse events will be reported per protocol. A safety monitoring designee will perform reviews on a designated basis throughout the study.
Study Costs There will be no additional cost to the patient for their participation in this study. No additional laboratory testing will be performed as a result of participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrofurantoin | Active comparator | Drug: NitrofurantoinNitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo drug 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing urogynecologic surgery
- Receive postoperative catheterization
Key exclusion criteria (7 listed)
- Age less than 21 years old
- Pregnancy
- Allergy, contraindication or intolerance to Nitrofurantoin
- Do not speak English
- Dependent on trans-urethral catheter to accomplish voiding preoperatively
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 |
|---|---|---|
| NitrofurantoinAlso: Macrobid, MacrodantinNitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively | Drug | Nitrofurantoin |
| PlaceboAlso: Placebo medication, Inactive medicationParticipants randomized to placebo will be instructed to take placebo one tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization | Drug | Placebo |
Primary outcome
Urinary Tract Infections
Time frame: three weeks post-operative
The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.
7 secondary outcomes
Other Risk Factors for UTI
Time frame: 3 weeks following surgery
Other Risk Factors for UTI
Time frame: 3 weeks following surgery
Other Risk Factors for UTI
Time frame: 3 weeks following surgery
Other Risk Factors for UTI
Time frame: 3 weeks following surgery
Other Risk Factors for UTI
Time frame: 3 weeks following surgery
Other Risk Factors for UTI
Time frame: 3 weeks following surgery
Other Risk Factors for UTI
Time frame: 3 weeks following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10389720Brown JS, Grady D, Ouslander JG, Herzog AR, Varner RE, Posner SF. Prevalence of urinary incontinence and associated risk factors in postmenopausal women. Heart & Estrogen/Progestin Replacement Study (HERS) Research Group. Obstet Gynecol. 1999 Jul;94(1):66-70. doi: 10.1016/s0029-7844(99)00263-x.
- Background: PubMed 11106889Hannestad YS, Rortveit G, Sandvik H, Hunskaar S; Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol. 2000 Nov;53(11):1150-7. doi: 10.1016/s0895-4356(00)00232-8.
- Background: PubMed 17049716Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
- Background: PubMed 7427654Thomas TM, Plymat KR, Blannin J, Meade TW. Prevalence of urinary incontinence. Br Med J. 1980 Nov 8;281(6250):1243-5. doi: 10.1136/bmj.281.6250.1243.
- Background: PubMed 19935030Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
- Background: PubMed 14694449Levin I, Groutz A, Gold R, Pauzner D, Lessing JB, Gordon D. Surgical complications and medium-term outcome results of tension-free vaginal tape: a prospective study of 313 consecutive patients. Neurourol Urodyn. 2004;23(1):7-9. doi: 10.1002/nau.10164.
- Background: PubMed 11450979Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8. doi: 10.1007/s001920170003.
- Background: PubMed 18401538Falagas ME, Athanasiou S, Iavazzo C, Tokas T, Antsaklis A. Urinary tract infections after pelvic floor gynecological surgery: prevalence and effect of antimicrobial prophylaxis. A systematic review. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1165-72. doi: 10.1007/s00192-008-0584-0. Epub 2008 Apr 10.
- Background: PubMed 19582384Sutkin G, Lowder JL, Smith KJ. Prophylactic antibiotics to prevent urinary tract infection during clean intermittent self-catheterization (CISC) for management of voiding dysfunction after prolapse and incontinence surgery: a decision analysis. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Aug;20(8):933-8. doi: 10.1007/s00192-009-0885-y. Epub 2009 Apr 10.
- Background: PubMed 19635279Macy E, Poon K-Y T. Self-reported antibiotic allergy incidence and prevalence: age and sex effects. Am J Med. 2009 Aug;122(8):778.e1-7. doi: 10.1016/j.amjmed.2009.01.034.
- Derived from this study: PubMed 24463669Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024.
Related trials for Urinary Tract Infection
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
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
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.
Cindy Amundsen, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrofurantoin in people with Urinary Tract Infection, run by Duke 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 2 inclusion and 7 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 13 Feb 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Urinary Tract Infections (time frame: three weeks post-operative). 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 NCT01450800, which also lists 11 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 13 Feb 2017.