Effectiveness of Three Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03269604
• Date of registration: 30/08/2017
• Prospective Registration: Yes
• Primary sponsor: Jorge Andres Ramos Castaneda
• Public title: Effectiveness of Three Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria.
• Scientific title: Effectiveness of Three Different Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria Scheduled for Urological Surgery. A Randomized Multicentric Clinical Trial
• Date of first enrolment: January 22, 2018
• Target sample size: 456
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03269604
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Colombia

Contacts

• Name: Jorge A Ramos, Ph.D Stud

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asymptomatic Bacteriuria

Antibiotic Prophylaxis

Intervention(s)

Procedure: Prophylactic antibiotic during three days previous to the procedure

Procedure: Only a single dose of Prophylactic antibiotic

Procedure: Prophylactic antibiotic during five days previous to the procedure

Primary Outcome(s)

Bloodstream infection [Time Frame: 30 days]

Secondary Outcome(s)

Length of hospital stay [Time Frame: 30 days]

Re-entry to hospitalization [Time Frame: 30 days]

Surgical Site Infection: [Time Frame: 30 days]

Secondary ID(s)

1075237598

Source(s) of Monetary Support

Please refer to primary and secondary sponsors