Protocol summary

Summary
In this double blind prospective clinical trial, all patients with kidney stones and ureteral lithotripsy attended to the Babol Clinic 2014-2015 were enrolled. Inclusion criteria: minimum age 18 years, negative urine culture before ESWL; absence of Foley catheter or nephrostomy tube; no history of infectious stones. Exclusion criteria: patients who have not had suitable follow up; those who have done urine culture in the 2 weeks after ESWL; manipulation of the urinary system during and after ESWL. Patients are divided into two groups of A and B. Group A will be given 200 mg of Ofloxacin every 12 hours, preferably after surgery for up to 3 days and group B will be given placebo which is a pill made from flour. Then in all patients, 5 days before crusher surgery, urine culture will be done. Two weeks after ESWL, urine culture and ultrasound will be done and the information will be collected. Variables include size of the stones, the number and location of the stone, the Double j over the crusher. First variables will be given, including the amount of wave energy and crushed stone (immediately after ESWL) in the final stage of gathering information. Then we will check the following variables: the amount of crushed stone, the presence of renal colic after ESWL (response to oral pain medications and intravenous), the remaining stones larger than 5 mm ultrasound controls, urine culture results (presence of a colony of 105 ml / CFU to culture is seen as positive), urinary tract infection symptoms, frequency and urgency with positive culture, urinary sepsis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062422897N1
Registration date: 2015-11-25, 1394/09/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-25, 1394/09/04
Registrant information
Name
masomeh bayani
Name of organization / entity
medical university of babol
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
m_baiany@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancelor of Babol University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of antibiotic prophylaxis during extracorporeal shock wave lithotripsy(ESWL) in prevention of urinary tract infections in patients with urine proven sterile prior to treatment
Public title
Efficacy of antibiotic prophylaxis during extracorporeal shock wave lithotripsy in prevention of urinary tract infections in patients with urine proven sterile prior to treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: minimum age 18 years; negative urine culture before ESWL; absence of Foley catheter or nephrostomy tube; no history of infectious stones. Exclusion criteria: patients who have not had suitable follow up; those who have done urine culture in the 2 weeks after ESWL; manipulation of the urinary system during and after ESWL.
Age
From 18 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Rohani Hospital
City
Babol
Postal code
47176-41367
Approval date
2015-06-07, 1394/03/17
Ethics committee reference number
MUBABOL.REC.1394.30

Health conditions studied

1

Description of health condition studied
UTI
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter

Primary outcomes

1

Description
The incidence of urinary tract infections was measured among patients without risk factors.
Timepoint
Urine analysis was performed 5 days before ESWL surgery.
Method of measurement
Calculate number organisms in the urine according to CFU.

Secondary outcomes

1

Description
Increased antibiotic resistance and drug side effects and interactions compared with placebo has occurred.
Timepoint
monthly
Method of measurement
Urine culture and physical examination

Intervention groups

1

Description
Patients are divided into two groups of A and B. Group A (the intervention group) will be given 200 mg of Ofloxacin every 12 hours.
Category
Treatment - Drugs

2

Description
Group B ( control group) will be given placebo which is a pill made from flour.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Private Babol Clinic Hospital
Full name of responsible person
Dr.Hamid Shafie
Street address
Babol University of Medical Sciences- Medicine faculty
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hamid Shafie
Street address
Babol University of Medical Sciences, Gangafrooz street, Daneshgah squer
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hamid Shafie
Position
Urology specialist
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Gangafrooz street, Daneshgah squer
City
Babol
Postal code
Phone
+98 11 3219 2832
Fax
Email
dr_hamidshafi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Masomeh Bayani
Position
Infectious specialist
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Gangafrooz street, Daneshgah squer
City
babol
Postal code
4717641367
Phone
+98 11 3219 2832
Fax
+98 11 3219 2832
Email
m_baiany@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Masomeh Ilkhani
Position
Medical students
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Gangafrooz street, Daneshgah squer
City
Babol
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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