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

Not Applicable

• Conditions: Antimicrobial Prophylaxis; Asymptomatic Bacteriuria
• Interventions: Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL

• Registration Number: NCT04152369
• Lead Sponsor: Military Institute od Medicine National Research Institute

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.

Study Timeline

• Study Start: 2016-07-15
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 hour prophylaxis	Anti-microbial prophylaxis for an endourological procedure or ESWL	In this group patients received a AMP for the day of the procedure
72 hour prophylaxis	Anti-microbial prophylaxis for an endourological procedure or ESWL	In this group patients received a AMP one day prior, on the day of the procedure and the following day.

Primary Outcome Measures

Name	Time	Method
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 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.

Trial Locations

Locations (1)

Military Institue of Medicine; 🇵🇱 Warsaw, Mazowieckie, Poland