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

Sponsor

Military Institute of Medicine, Poland (Other)

Overall Status

Unknown status

CT.gov ID

NCT04152369

Collaborator

(none)

Enrollment

Location

Arms

47.5

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antimicrobial Prophylaxis Asymptomatic Bacteriuria	Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

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"

Actual Study Start Date :

Jul 15, 2016

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 24 hour prophylaxis In this group patients received a AMP for the day of the procedure	Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL anti-microbial prophylaxis according to urine culture results
Active Comparator: 72 hour prophylaxis In this group patients received a AMP one day prior, on the day of the procedure and the following day.	Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL anti-microbial prophylaxis according to urine culture results

Arm

Intervention/Treatment

Active Comparator: 24 hour prophylaxis

In this group patients received a AMP for the day of the procedure

Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL

anti-microbial prophylaxis according to urine culture results

Active Comparator: 72 hour prophylaxis

In this group patients received a AMP one day prior, on the day of the procedure and the following day.

Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL

anti-microbial prophylaxis according to urine culture results

Outcome Measures

Primary Outcome Measures

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.
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 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.
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 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Military Institue of Medicine	Warsaw	Mazowieckie	Poland	04-141

Sponsors and Collaborators

Military Institute of Medicine, Poland

Investigators

Principal Investigator: Marcin A Radko, MD, Military Institute of Medicine
Study Chair: Henryk Zieliński, Professor, Military Institute of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marcin Radko, Principal Investigator, Military Institute of Medicine, Poland

ClinicalTrials.gov Identifier:

NCT04152369

Other Study ID Numbers:

0000000495

First Posted:

Nov 5, 2019

Last Update Posted:

Feb 20, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marcin Radko, Principal Investigator, Military Institute of Medicine, Poland

ESBL+

Antimicrobial prophylaxis

Additional relevant MeSH terms:

Bacteriuria

Anti-Infective Agents

Anti-Bacterial Agents

Study Results

No Results Posted as of Feb 20, 2020