Evaluation of the specific bacteriophages to control of E.coli in patients with antibiotic-resistant urinary tract infections
Design
A clinical trial with two groups of patients: parallel, therapeutic, blanced block randomization, double-blind (patient and physician). 20 patients referred to Sinai Hospital.
Settings and conduct
20 patients at Sina Hospital. blanced block randomization, double-blind (patient and physician). Patients are divided into two groups: Group 1: Rinsing the bladder with physiological saline plus phosphate buffer salt (PBS). Group 2: physiological saline plus Purified specific bacteriophage.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with recurrent urinary tract infections more than 3 positive cultures per year with E.coli, Age range 20-70 years, Consent to participate in the study.
Exclusion criteria: pregnant women, Patients with allergies
Intervention groups
Control group: Rinsing the bladder with physiological saline with 20 cc of phosphate buffer salt.
Intervention group: Rinsing the bladder with physiological saline with 20 cc of Purified specific bacteriophage.
Evaluation of the specific bacteriophages to control of E.coli in patients with antibiotic-resistant urinary tract infections
Public title
Evaluation of the specific bacteriophages to control of E.coli
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with recurrent urinary tract infections more than 3 positive cultures per year with E.coli
Age range 20-70 years
Consent to participate in the study
Exclusion criteria:
pregnant women
Patients with allergies
Age
From 20 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a double-blind randomized clinical trial. For randomization, the blanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined. According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the sealdenvelop (for create a randomisation list) online site, the generated sequence will be made available to a technician outside the research team. Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician. The patient is placed in Control group: Rinsing the bladder with physiological saline with 20 cc of phosphate buffer salt (PBS) or Intervention group: Rinsing the bladder with physiological saline with 20 cc of Purified specific bacteriophage based on the randomly selected envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who have agreed to participate in the study and the therapist for the blinding process, envelopes related to the type of intervention are provided only to the technician. The physician (to avoid bias) and the patient are not informed of the type of intervention (physiological saline plus phosphate buffer salt or physiological saline plus Purified specific bacteriophage).
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees in Medical Medical Research
Street address
Room 604, Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-06-06, 1400/03/16
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.221
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
urinary bacteria in patients with antibiotic-resistant urinary tract infections
Timepoint
Twice a week for three consecutive months
Method of measurement
Collect patients' urine samples and check the bacteria count
2
Description
frequent urination in patients with antibiotic-resistant urinary tract infections
Timepoint
Twice a week for three consecutive months
Method of measurement
Collect patients' urine samples and check the bacteria count
3
Description
dysuria in patients with antibiotic-resistant urinary tract infections
Timepoint
Twice a week for three consecutive months
Method of measurement
Collect patients' urine samples and check the bacteria count
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Rinsing the bladder with physiological saline with 20 cc of phosphate buffer salt (PBS), Twice a week for three consecutive months.
Category
Placebo
2
Description
Intervention group: Rinsing the bladder with physiological saline with 20 cc of Purified specific bacteriophage, Twice a week for three consecutive months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sixth Floor, Central University, Keshavarz Boulevard, Quds Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
demographic information anonymously
When the data will become available and for how long
one year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.