An interventional study of Anti-microbial prophylaxis for an endourological procedure or ESWL in Antimicrobial Prophylaxis and Asymptomatic Bacteriuria, sponsored by Military Institute od Medicine National Research Institute. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Military Institute od Medicine National Research Institute · Not applicable, Interventional, and Health services research
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.
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 37 interventional studies indexed under Bacteriuria.
Browse Bacteriuria studies →Military Institute od Medicine National Research Institute is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
In this group patients received a AMP for the day of the procedure
Procedure: 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.
Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL
anti-microbial prophylaxis according to urine culture results
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
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.
Time frame: 7 days
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
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.
Time frame: 7 days
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
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.
Time frame: 7 days
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
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.
Time frame: 7 days
Plan to share: No
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Started Jul 2016 (actual). Primary completion is estimated for Jun 2020, 47 months after the start.
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This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Military Institute od Medicine National Research Institute