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

NCT ID: NCT04152369

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-15

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Antimicrobial Prophylaxis Asymptomatic Bacteriuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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24 hour prophylaxis

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

Group Type ACTIVE_COMPARATOR

Anti-microbial prophylaxis for an endourological procedure or ESWL

Intervention Type PROCEDURE

anti-microbial prophylaxis according to urine culture results

72 hour prophylaxis

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

Group Type ACTIVE_COMPARATOR

Anti-microbial prophylaxis for an endourological procedure or ESWL

Intervention Type PROCEDURE

anti-microbial prophylaxis according to urine culture results

Interventions

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Anti-microbial prophylaxis for an endourological procedure or ESWL

anti-microbial prophylaxis according to urine culture results

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Institute od Medicine National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Marcin Radko

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcin A Radko, MD

Role: PRINCIPAL_INVESTIGATOR

Military Institute of Medicine

Henryk ZieliƄski, Professor

Role: STUDY_CHAIR

Military Institute of Medicine

Locations

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Military Institue of Medicine

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marcin A Radko, MD

Role: CONTACT

+48603768924

Facility Contacts

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Marcin A Radko, MD

Role: primary

+48 603768924

Malgorzata Kowanska

Role: backup

Other Identifiers

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0000000495

Identifier Type: -

Identifier Source: org_study_id

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