"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"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Antimicrobial Prophylaxis
- Sponsor
- Military Institute od Medicine National Research Institute
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Marcin Radko
Principal Investigator
Military Institute od Medicine National Research Institute
Eligibility Criteria
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
- •non ESBL+ bacteriuria
- •inability to consent
Outcomes
Primary Outcomes
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.