Ignite Creation Date:
2024-05-05 @ 11:57 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01450800
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
2011-10-10
Brief Title:
Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection UTI
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOPP UTI
Brief 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
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 005 we would need 156 subjects to demonstrate a 66 reduction in risk of UTI ie 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 ie 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 andor 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
Sample Size Under the assumption of 80 power and an alpha error of 005 we would need 156 subjects to demonstrate a 66 reduction in risk of UTI ie 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 ie 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3913577 | OTHER_GRANT | Charles B Hammond Research Fund | None |