Prophylactic antibiotic in patients who undergo cystoscopy with urine sterile: a double blind controlled clinical trial

What is the efficacy of antibiotic (levofloxacin) prophylaxis compared with placebo in patients of both genders aged 18 years and above who are undergoing cystoscopy with sterile urine in decreasing the incidence of urinary tract infection?

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000750987

Enrollment

300

Registered

2011-07-18

Start date

2012-07-20

Completion date

2012-07-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There will be a double-blind controlled clinical trial Multicentre, with the aim of providing critical information for making decisions regarding the use of antibiotic prophylaxis in patients who undergo outpatient cystoscopy. It makes the next project is to determine for 2011, the effectiveness of antibiotic prophylaxis in patients with sterile urine, will be to establish the incidence of urinary tract infection in each group as the primary outcome variable and determine the possible complications and effects adverse experimental therapy. Will take care of the proper use of the principles of medical ethics such as: justice, beneficence and respect.

Interventions

Intervention group: Prophylactic antibiotic levofloxacin 500 mg orally single dose 30 to 60 minutes before the cystoscopy

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients over 18 years, with cystoscopy for any cause, negative urine culture, those who sign in the consent to participate in the study.

Exclusion criteria

Inability to track or allergy to antibiotic use, or interactions with other drugs, with specific indication for prophylaxis (Pe prosthetic heart valve, heart murmur, prosthetic orthopedic or vascular), taking antibiotics at the time of the procedure, who have a permanent urethral catheter, patients with immunosuppression, spinal cord injury that required catheterization, who were let urethral catheter after the procedure (Exclusions post-randomisation).

Outcome results