Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000750987
Ethics application status
Approved
Date submitted
16/07/2011
Date registered
18/07/2011
Date last updated
3/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Prophylactic antibiotic in patients who undergo cystoscopy with urine sterile: a double blind controlled clinical trial
Scientific title
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?
Secondary ID [1] 262639 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prophylactic antibiotic use in cystoscopy to decrease the incidence of urinary tract infection 268351 0
Condition category
Condition code
Renal and Urogenital 268480 268480 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Prophylactic antibiotic levofloxacin 500 mg orally single dose 30 to 60 minutes before the cystoscopy
Intervention code [1] 266990 0
Treatment: Drugs
Intervention code [2] 266995 0
Prevention
Comparator / control treatment
Control: placebo tablet with the same characteristics in the form to the antibiotic given to the experimental group, single oral dose 30 to 60 minutes before the procedure. I clarify that placebo has not the actual active ingredient of the true drug (levofloxacin)
Control group
Placebo

Outcomes
Primary outcome [1] 269227 0
To determine the efficacy of prophylactic antibiotic use prior to cystoscopy in outpatients in decreasing the incidence of postprocedure urinary tract infection.
Urinary tract infection will be assessed by clinical assessment (asking for lower urinary tract symptoms) and by urine culture taking 3 -5 days after cystoscopy, both of them positive. It will be assessed as a categorical variable yes or no (positive or negative).
Timepoint [1] 269227 0
Maximum ten days after randomization.
While reviewing literature we found that outcomes were assessed during these first ten days, it?s arbitrary but after this day one can find that any etiology other than the procedure can cause a urinary tract infection.
Secondary outcome [1] 279161 0
To determine the incidence of postprocedure asymptomatic bacteriuria in both groups.

Asymptomatic bateriuria will be assessed by clinical assessment (asking for lower urinary tract symptoms) and by urine culture taking 3 -5 days after cystoscopy.
Urine culture will be negative and symptoms will be positive . It?ll be assessed as a categorical variable yes or no (positive or negative).
Timepoint [1] 279161 0
Maximum ten days after randomization.
While reviewing literature we found that outcomes were assessed during these first ten days, it?s arbitrary but after this day one can find that any etiology other than the procedure can cause a asymptomatic bacteriuria.
Secondary outcome [2] 279162 0
To establish the incidence of complications associated with the procedure.

Urinary retencion: Complete inhability to void. -- Clinical assessment.

Sepsis: UTI plus systemic inflammatory response signs -- Clinical assessment.

Hematuria: Bleeding in urine (including clots) -- Clinical assessment

Bladder perforation: Presence of a perforation in the bladder during the procedure -- Clinical asessment

Hospitalizacion: Requirement to act as inpatient for bladder perforation, sepsis, hematuria or other.
Timepoint [2] 279162 0
maximum ten days after randomization.
While reviewing literature we found that outcomes were assessed during these first ten days, it?s arbitrary but after this day one can find that any etiology other than the procedure can cause a complication.
Secondary outcome [3] 279163 0
To Identify adverse effects presented by the drug administered.

Nausea: Feeling like vomiting -- Clinical assessment

Emesis: Output of food from mouth --- clinical assessment

Diarrhea: Loose stools with increased frequency --- clinical assessment.

Headache: Pain in the head. --- Clinical assessment

Delirium: False belief not supported by your social group belonging. Idea firmly held and not be corrected by the logic. ---- Clinical assessment

Hallucinations: Perception that does not correspond to any external physical stimulus --- Clinical assessment

Seizures: Generalized tonic and clonic movements or targeted with or without loss of consciousness --- clinical assessment

Exanthema: Changes in erythematous, scaly skin --- Clinical assessment

pruritus: Itching in the patient's body --- Clinical assessment
Timepoint [3] 279163 0
Maximum ten days after randomization.
While reviewing literature we found that outcomes were assessed during these first ten days, it?s arbitrary but after this day one can find that any etiology other than the tablet can cause a reaction.
Secondary outcome [4] 279164 0
To Identify microorganisms involved in urinary tract infection postprocedure and antibiotic sensitivity pattern.
Assessed by urine culture 3 -5 days after cystoscopy.
Timepoint [4] 279164 0
Maximum ten days after randomization (It?s evaluated 3 to 5 days after cystoscopy but if patient has any trouble to take the test we can wait up to 10 days)
While reviewing literature we found that outcomes were assessed during these first ten days, it?s arbitrary but after this day one can find that any etiology other than the procedure can cause a urinary tract infection or asymptomatic bacteriuria.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
For the assignment of each patient in the experimental group or control group in the study it is conducted a stratified randomization.
In the allocation of treatment once the patient is included in the study, sealed envelopes will contain the respective code generated randomization in blocks and will open in consecutive order in the order of arrival of patients at each center. The envelope will only be opened once the patient signs informed consent. In sealed boxes marked with the appropriate drug code on the outside, were stored the drug or placebo to be administered, both in the same presentation and same number of tablets. Medications will be administered by a nursing assistant in each school and as the treating physician, blinded to the intervention will be offered to the patient.
The placebo will be conducted by an external laboratory in tablets of identical presentation to Levofloxacin 500 mg.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In each of the centers perform randomization by permuted blocks of variable size to ensure a similar number of patients in each group.
The generation of the sequence will be done by computer for each site independently by a person outside the research group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2011
Actual
20/07/2012
Date of last participant enrolment
Anticipated
Actual
20/07/2012
Date of last data collection
Anticipated
Actual
20/07/2012
Sample size
Target
300
Accrual to date
Final
300
Recruitment outside Australia
Country [1] 3736 0
Colombia
State/province [1] 3736 0
Valle del Cauca
Country [2] 3737 0
Colombia
State/province [2] 3737 0
Bogota - Cali

Funding & Sponsors
Funding source category [1] 267463 0
Self funded/Unfunded
Name [1] 267463 0
Country [1] 267463 0
Colombia
Primary sponsor type
Individual
Name
Herney Garcia
Address
Address: Cr 35 #3a-38 ap 301
State: Valle del cauca
City: Cali
Country
Colombia
Secondary sponsor category [1] 266507 0
None
Name [1] 266507 0
Address [1] 266507 0
Country [1] 266507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269434 0
Comite institucional de revision de etica humana (CIREH)
Ethics committee address [1] 269434 0
Ethics committee country [1] 269434 0
Colombia
Date submitted for ethics approval [1] 269434 0
27/09/2010
Approval date [1] 269434 0
27/10/2010
Ethics approval number [1] 269434 0
Approval act No 017-010 Internal code: 161-010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32885 0
Prof Herney Andrés garcía-Perdomo
Address 32885 0
Cll 4b # 36-00, Cali, 164, Valle.
Country 32885 0
Colombia
Phone 32885 0
+57 321 2195102
Fax 32885 0
Email 32885 0
[email protected]
Contact person for public queries
Name 16132 0
Herney Andres Garcia Perdomo
Address 16132 0
Address: Cr 35 #3a-38 ap 301
State: Valle del cauca
City: Cali
Country 16132 0
Colombia
Phone 16132 0
+57 2 3174354600
Fax 16132 0
Email 16132 0
[email protected]
Contact person for scientific queries
Name 7060 0
Herney Andres Garcia Perdomo
Address 7060 0
Address: Cr 35 #3a-38 ap 301
State: Valle del cauca
City: Cali
Country 7060 0
Colombia
Phone 7060 0
+57 2 3174354600
Fax 7060 0
Email 7060 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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