- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04152369
"Peri-operative Antimicrobial Prophylaxis in Patients With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin" (ESBL)
February 19, 2020 updated by: Marcin Radko, Military Institute of Medicine, Poland
"Comparison of the Effectiveness of 24-hour and 72-hour Peri-procedural Antimicrobial Prophylaxis in Patients Undergoing Endourological Procedures and ESWL Presenting With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin"
The aim of the study is to determine optimal safe duration of antibiotic prophylaxis in patients undergoing endourological procedures and ESWL, presenting with asymptomatic bacteriuria caused by multi-drug resistant bacterial strains.
In this study we compare safety and efficacy of a one-day vs. three-day AMP (Antimicrobial Prophylaxis) in the above mentioned group of patients.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Patients with positive urine culture with Enterobacteriacae ESBL + resistance mechanism upon admission for endourological procedure or ESWL were subjected to body temperature measurement and laboratory tests: smear from the anus towards the presence of alarm pathogens, urinalysis, control urine culture, blood count, CRP (C-reactive protein), procalcitonin (PCT).
After confirming the occurrence of asymptomatic bacteriuria, the patients were randomized to two groups - a one-day and three-day period lasting perioperative antibiotic prophylaxis.
In both groups on the following day after the procedure (24 hours after the procedure) and after 7 days after the procedure, laboratory tests and body temperature measurements were performed.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marcin A Radko, MD
- Phone Number: +48603768924
- Email: mradko@wim.mil.pl
Study Locations
-
-
Mazowieckie
-
Warsaw, Mazowieckie, Poland, 04-141
- Recruiting
- Military Institue of Medicine
-
Contact:
- Marcin A Radko, MD
- Phone Number: +48 603768924
- Email: mradko@wim.mil.pl
-
Contact:
- Malgorzata Kowanska
- Email: mkowanska@wim.mil.pl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ESBL+ asymptomatic bacteriuria
- assigned for endourological procedure
- normal CRP, PCT and WBC
- patient's consent
Exclusion Criteria:
- urinary tract infection
- raised levels of CRP, PCT, WBC
- fever
- non ESBL+ bacteriuria
- inability to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 24 hour prophylaxis
In this group patients received a AMP for the day of the procedure
|
anti-microbial prophylaxis according to urine culture results
|
ACTIVE_COMPARATOR: 72 hour prophylaxis
In this group patients received a AMP one day prior, on the day of the procedure and the following day.
|
anti-microbial prophylaxis according to urine culture results
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
Time Frame: 7 days
|
To determine if a 1-day perioperative antibiotic prophylaxis is as safe and effective as 3-day perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures.
This conclusion will be based on measurements of CRP [mg/dl] as follows: one day prior to procedure, one day post and 7 days after the procedure.
The data will be statistically analyzed.
|
7 days
|
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
Time Frame: 7 days
|
To determine if a 1-day perioperative antibiotic prophylaxis is as safe and effective as 3-day perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures.
This conclusion will be based on measurements of WBC level [x 10^9/l] as follows: one day prior to procedure, one day post and 7 days after the procedure.
The data will be statistically analyzed.
|
7 days
|
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
Time Frame: 7 days
|
To determine if a 1-day perioperative antibiotic prophylaxis is as safe and effective as 3-day perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures.
This conclusion will be based on measurements of levels of prokalcytonin [ng/ml] as follows: one day prior to procedure, one day post and 7 days after the procedure.
The data will be statistically analyzed.
|
7 days
|
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
Time Frame: 7 days
|
To determine if a 1-day perioperative antibiotic prophylaxis is as safe and effective as 3-day perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures.
This conclusion will be based on measurements of body temperature [Celsius] as follows: one day prior to procedure, one day post and 7 days after the procedure.
The data will be statistically analyzed.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marcin A Radko, MD, Military Institute of Medicine
- Study Chair: Henryk Zieliński, Professor, Military Institute of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 15, 2016
Primary Completion (ANTICIPATED)
June 30, 2020
Study Completion (ANTICIPATED)
June 30, 2020
Study Registration Dates
First Submitted
October 29, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (ACTUAL)
November 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 20, 2020
Last Update Submitted That Met QC Criteria
February 19, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000000495
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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