"Peri-operative Antimicrobial Prophylaxis in Patients With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin"
ESBL
"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"
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2016
CompletedFirst Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedFebruary 20, 2020
February 1, 2020
4 years
October 29, 2019
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
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).
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).
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).
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
Study Arms (2)
24 hour prophylaxis
ACTIVE COMPARATORIn this group patients received a AMP for the day of the procedure
72 hour prophylaxis
ACTIVE COMPARATORIn this group patients received a AMP one day prior, on the day of the procedure and the following day.
Interventions
anti-microbial prophylaxis according to urine culture results
Eligibility Criteria
You may qualify if:
- ESBL+ asymptomatic bacteriuria
- assigned for endourological procedure
- normal CRP, PCT and WBC
- patient's consent
You may not qualify if:
- urinary tract infection
- raised levels of CRP, PCT, WBC
- fever
- non ESBL+ bacteriuria
- inability to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Military Institue of Medicine
Warsaw, Masovian Voivodeship, 04-141, Poland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcin A Radko, MD
Military Institute of Medicine
- STUDY CHAIR
Henryk Zieliński, Professor
Military Institute of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 29, 2019
First Posted
November 5, 2019
Study Start
July 15, 2016
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share