Clinical trial NCT04152369: "Peri-operative Antimicrobial Prophylaxis in Patients With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin"
Official title: "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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antimicrobial Prophylaxis
Asymptomatic Bacteriuria
Keywords: ESBL+
Antimicrobial prophylaxis
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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
* fever
* non ESBL+ bacteriuria
* inability to consent

Primary outcomes:
measure: Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
timeFrame: 7 days
measure: Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
timeFrame: 7 days
measure: Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
timeFrame: 7 days
measure: Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institue of Medicine
state: Mazowieckie
Study officials:
affiliation: Military Institute of Medicine
name: Marcin A Radko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Military Institute of Medicine
name: Henryk Zieliński, Professor
role: STUDY_CHAIR
References: