Asymptomatic BacteriuriaNCT03269604
Effectiveness of Three Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria.
A study testing Prophylactic antibiotic during five days previous to the procedure, Prophylactic antibiotic during three days previous to the procedure and Only a single dose of Prophylactic antibiotic in people with Asymptomatic Bacteriuria and Antibiotic Prophylaxis, run by Jorge Andres Ramos Castaneda at 1 site in Colombia.
Trial summary
Asymptomatic bacteriuria (AB) is the isolation of a bacterium in a sample of urine appropriately collected from a person who does not have signs or symptoms of urinary infection. It is common in diabetic women, in pregnant women, in men over 60 years and in patients with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asymptomatic Bacteriuria, Antibiotic Prophylaxis
- What is being tested?
- Prophylactic antibiotic during five days previous to the procedure, Prophylactic antibiotic during three days previous to the procedure and Only a single dose of Prophylactic antibiotic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteColombia
- Study dates
- 22 Jan 2018to Nov 2018
- 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
- Age ≥ 18 years
- Patients with asymptomatic bacteriuria identified with a urine culture prior to the surgical procedure and with a microorganism that meets the following criteria: 1) gram-negative bacteria in the enterobacterial family and non-fermenting bacilli; 2) Bacteria with resistance profile has a therapeutic option that reaches therapeutic concentration in urine.
- Patients scheduled for urological procedures, such as: transurethral resection of the prostate, open prostatectomy, cystoscopy, extracorporeal lithotripsy and flexible ureterorenoscopy.
- Informed consent
Who cannot join
- Patients with chronic renal failure; with immunosuppressive status secondary to glucocorticoid consumption, haematological or solid organ neoplasms undergoing chemotherapy or radiation therapy or neutropenia.
- Patients with active infection or clinical criteria of urinary infection.
- Patients who voluntarily do not want to participate in the study.
- Patients who can not give informed consent under reasonable or vulnerable conditions.
- Patients who present type I allergy to penicillin.
- Patients who have scheduled surgeries combined with a discipline different to urology.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Universidad CES
Medellín, Antioquia, 00000
Jorge A Ramos, Ph.D Stud, +57 (4) 4440555, ramos.jorge@uces.edu.co
Jorge A Ramos, Ph.D Stud
About this study
Official title: Effectiveness of Three Different Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria Scheduled for Urological Surgery. A Randomized Multicentric Clinical Trial
Asymptomatic bacteriuria (AB) is the isolation of a bacterium in a sample of urine appropriately collected from a person who does not have signs or symptoms of urinary infection. It is common in diabetic women, in pregnant women, in men over 60 years and in patients with spinal cord injury.
There is clinical evidence that AB should be treated in patients who will be operated on with urologic surgery because of the risk of presenting infectious complications; however, the timing of initiating antibiotic therapy has not been established, even in some studies the prophylaxis has been considered from one to seven days prior to the procedure, without determining the differences in the outcome for each one of the interventions and causing an undue and risky use of antibiotics.
Read more
A randomized, parallel-design, single-masked clinical trial will be performed to compare and analysis the bloodstream infections, surgical site infections, readmissions and hospital stay in three intervention groups, 1) those receiving antibiotics during the previous 5 days to the procedure; 2) 3 days prior to the procedure; and 3) those who receive only a single dose of antibiotic on the day of the procedure.
The main expected result is to identify the timing of initiation of antibiotic prophylaxis in urological procedures in patients with asymptomatic bacteriuria, with the purpose of diminishing the bloodstream and of the surgical site infections. If it is scientifically demonstrated that those patients who receive a single dose of antibiotic on the same day of the procedure, have the same safety and effectiveness compared to the other two groups, would reduce hospital stay, surgical waiting time and indiscriminate use of antibiotics that generate multidrug-resistant microorganisms, thus generating an impact on Public Health and on the quality of care.
- Conditions
- Asymptomatic Bacteriuria, Antibiotic Prophylaxis
- Being tested
- Prophylactic antibiotic during five days previous to the procedure, Prophylactic antibiotic during three days previous to the procedure, Only a single dose of Prophylactic antibiotic
- Keywords
- Urological Surgery, Bacterial resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic antibiotic during five days previous to the procedureProcedure or surgery
Prophylactic antibiotic during five days previous to the procedure.
Prophylactic antibiotic during three days previous to the procedureProcedure or surgery
Prophylactic antibiotic during three days previous to the procedure.
Only a single dose of Prophylactic antibioticProcedure or surgery
This group will receive a single dose of antibiotic 90 ± 20 minutes prior to the start of the surgical procedure (incision)
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic antibiotic five days previous to the procedure | Active comparator | Prophylactic antibiotic during five days previous to the procedure. Receives: Procedure: Prophylactic antibiotic during five days previous to the procedure |
| Prophylactic antibiotic three days previous to the procedure | Active comparator | Prophylactic antibiotic during three days previous to the procedure. Receives: Procedure: Prophylactic antibiotic during three days previous to the procedure |
| Only a single dose of Prophylactic antibiotic | Experimental | Only a single dose of Prophylactic antibiotic on the day of the procedure Receives: Procedure: Only a single dose of Prophylactic antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bloodstream infection
An infectious process characterized by the presence of some bacteria in the bloodstream. The patient should have one or more positive blood cultures, where the cultured organism is not related to an infection elsewhere, and has signs of infection, such as fever, hypotension or tachycardia.
Measured: 30 days
Secondary outcomes (3)
Surgical Site Infection:
It can occur up to 30 days (or a year when a prosthetic component is involved) of a surgical procedure in some part of the body where it was manipulated in surgery. The SSI is classified as superficial, deep or organ space, depending on the type of tissue involved.
Measured: 30 days
Length of hospital stay
Difference in days between the date of discharge and of the surgical procedure.
Measured: 30 days
Re-entry to hospitalization
Re hospitalization after the surgical procedure due to SSI or bloodstream.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start22 Jan 2018
- Primary completionOct 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic BacteriuriaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jorge Andres Ramos Castaneda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorge Andres Ramos Castaneda, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269604
- Sponsor's protocol ID
- 1075237598
- Status last verified
- Jan 2018
- First submitted
- 30 Aug 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Three Different Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria Scheduled for Urological Surgery. A Randomized Multicentric Clinical Trial
- ClinicalTrials.gov ID
- NCT03269604
- Acronym / sponsor ID
- 1075237598
- Conditions
- Asymptomatic Bacteriuria, Antibiotic Prophylaxis
- Keywords
- Urological Surgery, Bacterial resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Jorge Andres Ramos CastanedaUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 1 Sep 2017 (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.
Asymptomatic bacteriuria (AB) is the isolation of a bacterium in a sample of urine appropriately collected from a person who does not have signs or symptoms of urinary infection. It is common in diabetic women, in pregnant women, in men over 60 years and in patients with spinal cord injury.
There is clinical evidence that AB should be treated in patients who will be operated on with urologic surgery because of the risk of presenting infectious complications; however, the timing of initiating antibiotic therapy has not been established, even in some studies the prophylaxis has been considered from one to seven days prior to the procedure, without determining the differences in the outcome for each one of the interventions and causing an undue and risky use of antibiotics.
A randomized, parallel-design, single-masked clinical trial will be performed to compare and analysis the bloodstream infections, surgical site infections, readmissions and hospital stay in three intervention groups, 1) those receiving antibiotics during the previous 5 days to the procedure; 2) 3 days prior to the procedure; and 3) those who receive only a single dose of antibiotic on the day of the procedure.
The main expected result is to identify the timing of initiation of antibiotic prophylaxis in urological procedures in patients with asymptomatic bacteriuria, with the purpose of diminishing the bloodstream and of the surgical site infections. If it is scientifically demonstrated that those patients who receive a single dose of antibiotic on the same day of the procedure, have the same safety and effectiveness compared to the other two groups, would reduce hospital stay, surgical waiting time and indiscriminate use of antibiotics that generate multidrug-resistant microorganisms, thus generating an impact on Public Health and on the quality of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prophylactic antibiotic five days previous to the procedure | Active comparator | Procedure: Prophylactic antibiotic during five days previous to the procedureProphylactic antibiotic during five days previous to the procedure. |
| Prophylactic antibiotic three days previous to the procedure | Active comparator | Procedure: Prophylactic antibiotic during three days previous to the procedureProphylactic antibiotic during three days previous to the procedure. |
| Only a single dose of Prophylactic antibiotic | Experimental | Procedure: Only a single dose of Prophylactic antibioticOnly a single dose of Prophylactic antibiotic on the day of the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients with asymptomatic bacteriuria identified with a urine culture prior to the surgical procedure and with a microorganism that meets the following criteria: 1) gram-negative bacteria in the enterobacterial family and non-fermenting bacilli; 2) Bacteria with resistance profile has a therapeutic option that reaches therapeutic concentration in urine.
- Patients scheduled for urological procedures, such as: transurethral resection of the prostate, open prostatectomy, cystoscopy, extracorporeal lithotripsy and flexible ureterorenoscopy.
- Informed consent
Key exclusion criteria (6 listed)
- Patients with chronic renal failure; with immunosuppressive status secondary to glucocorticoid consumption, haematological or solid organ neoplasms undergoing chemotherapy or radiation therapy or neutropenia.
- Patients with active infection or clinical criteria of urinary infection.
- Patients who voluntarily do not want to participate in the study.
- Patients who can not give informed consent under reasonable or vulnerable conditions.
- Patients who present type I allergy to penicillin.
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 |
|---|---|---|
| Prophylactic antibiotic during five days previous to the procedureProphylactic antibiotic during five days previous to the procedure. | Procedure or surgery | Prophylactic antibiotic five days previous to the procedure |
| Prophylactic antibiotic during three days previous to the procedureProphylactic antibiotic during three days previous to the procedure. | Procedure or surgery | Prophylactic antibiotic three days previous to the procedure |
| Only a single dose of Prophylactic antibioticThis group will receive a single dose of antibiotic 90 ± 20 minutes prior to the start of the surgical procedure (incision) | Procedure or surgery | Only a single dose of Prophylactic antibiotic |
Primary outcome
Bloodstream infection
Time frame: 30 days
An infectious process characterized by the presence of some bacteria in the bloodstream. The patient should have one or more positive blood cultures, where the cultured organism is not related to an infection elsewhere, and has signs of infection, such as fever, hypotension or tachycardia.
3 secondary outcomes
Surgical Site Infection:
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Re-entry to hospitalization
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic antibiotic during five days previous to the procedure, Prophylactic antibiotic during three days previous to the procedure and Only a single dose of Prophylactic antibiotic in people with Asymptomatic Bacteriuria and Antibiotic Prophylaxis, run by Jorge Andres Ramos Castaneda at 1 site in Colombia.
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 6 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 24 Jan 2018. 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 Colombia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bloodstream infection (time frame: 30 days). 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 24 Jan 2018.