Antimicrobial ProphylaxisESBLNCT04152369
"Peri-operative Antimicrobial Prophylaxis in Patients With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin"
A study testing Anti-microbial prophylaxis for an endourological procedure or ESWL in people with Antimicrobial Prophylaxis and Asymptomatic Bacteriuria, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antimicrobial Prophylaxis, Asymptomatic Bacteriuria
- What is being tested?
- Anti-microbial prophylaxis for an endourological procedure or ESWL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jul 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESBL+ asymptomatic bacteriuria
- assigned for endourological procedure
- normal CRP, PCT and WBC
- patient's consent
Who cannot join
- urinary tract infection
- raised levels of CRP, PCT, WBC
- fever
- non ESBL+ bacteriuria
- inability to consent
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Military Institue of Medicine
Warsaw, Masovian Voivodeship, 04-141
Marcin A Radko, MD, +48 603768924, mradko@wim.mil.pl
Malgorzata Kowanska, mkowanska@wim.mil.pl
About this study
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"
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.
Read the 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.
- Being tested
- Anti-microbial prophylaxis for an endourological procedure or ESWL
- Keywords
- ESBL+, Antimicrobial prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-microbial prophylaxis for an endourological procedure or ESWLProcedure or surgery
anti-microbial prophylaxis according to urine culture results
| Study group | Role | What they receive |
|---|---|---|
| 24 hour prophylaxis | Active comparator | In this group patients received a AMP for the day of the procedure Receives: Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL |
| 72 hour prophylaxis | Active comparator | In this group patients received a AMP one day prior, on the day of the procedure and the following day. Receives: Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start15 Jul 2016
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Radko, Military Institute od Medicine National Research Institute
- Investigators
- Marcin A Radko, MD, Principal investigator, Military Institute of MedicineHenryk Zieliński, Professor, Study chair, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152369
- Sponsor's protocol ID
- 0000000495
- Acronym
- ESBL
- Status last verified
- Feb 2020
- First submitted
- 29 Oct 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04152369
- Acronym / sponsor ID
- ESBL / 0000000495
- Keywords
- ESBL+, Antimicrobial prophylaxis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 hour prophylaxis | Active comparator | Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWLIn this group patients received a AMP for the day of the procedure |
| 72 hour prophylaxis | Active comparator | Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWLIn this group patients received a AMP one day prior, on the day of the procedure and the following day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ESBL+ asymptomatic bacteriuria
- assigned for endourological procedure
- normal CRP, PCT and WBC
- patient's consent
Key exclusion criteria (5 listed)
- urinary tract infection
- raised levels of CRP, PCT, WBC
- fever
- non ESBL+ bacteriuria
- inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-microbial prophylaxis for an endourological procedure or ESWLanti-microbial prophylaxis according to urine culture results | Procedure or surgery | 24 hour prophylaxis, 72 hour prophylaxis |
Primary outcome
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin A Radko, MD principal investigator
Military Institute of Medicine
Henryk Zieliński, Professor study chair
Military Institute of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-microbial prophylaxis for an endourological procedure or ESWL in people with Antimicrobial Prophylaxis and Asymptomatic Bacteriuria, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcin A Radko, MD (+48603768924, mradko@wim.mil.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy). (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.