Peri-operative Antimicrobial Prophylaxis in Patients With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04152369

Acronym

ESBL

Enrollment

Registered

2019-11-05

Start date

2016-07-15

Completion date

2020-06-30

Last updated

2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antimicrobial Prophylaxis, Asymptomatic Bacteriuria

Keywords

ESBL+, Antimicrobial prophylaxis

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.

Interventions

PROCEDUREAnti-microbial prophylaxis for an endourological procedure or ESWL

anti-microbial prophylaxis according to urine culture results

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).	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.

Countries

Poland

Contacts

Primary ContactMarcin A Radko, MD

mradko@wim.mil.pl+48603768924

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026