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

Military Institute od Medicine National Research Institute

Status: Unknown

Conditions: Asymptomatic Bacteriuria; Antimicrobial Prophylaxis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04152369

0000000495

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

24 hour prophylaxis

Active Comparator group

Description:

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

Treatment:

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

72 hour prophylaxis

Active Comparator group

Description:

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

Treatment:

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