An interventional study of Prophylactic antibiotic during five days previous to the procedure and Prophylactic antibiotic during three days previous to the procedure in Asymptomatic Bacteriuria and Antibiotic Prophylaxis, sponsored by Jorge Andres Ramos Castaneda. Status unknown at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-24.
Sponsored by Jorge Andres Ramos Castaneda · Not applicable, Interventional, and Prevention
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
This study's planned enrollment of 456 is above the median of 100 across 37 interventional studies indexed under Bacteriuria.
Browse Bacteriuria studies →This is the only study on the registry with Jorge Andres Ramos Castaneda as lead sponsor.
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Exclusion Criteria:
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prophylactic antibiotic during five days previous to the procedure.
Procedure: Prophylactic antibiotic during five days previous to the procedure
Prophylactic antibiotic during three days previous to the procedure.
Procedure: Prophylactic antibiotic during three days previous to the procedure
Only a single dose of Prophylactic antibiotic on the day of the procedure
Procedure: Only a single dose of Prophylactic antibiotic
Prophylactic antibiotic during five days previous to the procedure.
Prophylactic antibiotic during three days previous to the procedure.
This group will receive a single dose of antibiotic 90 ± 20 minutes prior to the start of the surgical procedure (incision)
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.
Time frame: 30 days
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.
Time frame: 30 days
Length of hospital stay
Difference in days between the date of discharge and of the surgical procedure.
Time frame: 30 days
Re-entry to hospitalization
Re hospitalization after the surgical procedure due to SSI or bloodstream.
Time frame: 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Oct 2018, 9 months after the start.
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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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