Evaluating the Effectiveness of Topical Vancomycin for the Treatment of Catheter Exit Infection in Children with Peritoneal Dialysis
Design
Semi-Experimental Non-randomized clinical trial No blinding or placebo on 40 patients
Settings and conduct
This Study is Conducted in Dr. Sheikh Hospital in Mashhad. Patients are treated with topical Vancomycin for 3 to 5 days and followed up for 6 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children from 2 months to 18 years old with Peritoneal Dialysis in Dr .Sheikh Hospital in Mashhad
Exclusion criteria: Children with Vancomycin Allergy and parents with dissatisfaction to participate
Intervention groups
Peritoneal Dialysis Children with Catheter Exit site Infection treated with Topical Vancomycin, does not have a control group.
Main outcome variables
Abundance and percentage of recovery of infection based on improvement of clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240106060632N1
Registration date:2024-08-12, 1403/05/22
Registration timing:prospective
Last update:2024-08-12, 1403/05/22
Update count:0
Registration date
2024-08-12, 1403/05/22
Registrant information
Name
Fatemeh Saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3878 4051
Email address
f.saberi.73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2025-02-17, 1403/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of local use of injectable vancomycin in preventing exit site infection in children with peritoneal dialysis
Public title
Determining the effect of local use of injectable vancomycin in preventing exit site infection in children with peritoneal dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Receiving Peritoneal Dialysis
2 Months to 18 years old
Not having a history of Vancomycin Allergy
Absence of Underlying Dermatologic Diseases based on initial clinical evaluation
Informed Consent
Not Receiving Systemic Antibiotics in last month
Exclusion criteria:
Sensitivity to Vancomycin
Younger than 2 Month old
Age
From 2 months old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Ethicscommittee , Mashhad University of Medical Sciences, Vakil Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177748153
Approval date
2023-09-09, 1402/06/18
Ethics committee reference number
IR.MUMS.REC.1402.162
Health conditions studied
1
Description of health condition studied
Exit site infection of peritoneal dialysis
ICD-10 code
K65.0
ICD-10 code description
Generalized (acute) peritonitis
Primary outcomes
1
Description
Peritoneal Dialysis exit site infection
Timepoint
1 Week , 3 Month , 6 Month
Method of measurement
Physical exam
Secondary outcomes
1
Description
Infectious Peritonitis
Timepoint
3 Month and 6 Month
Method of measurement
Clinical signs and peritoneal fluid culture
Intervention groups
1
Description
Intervention group: Intervention group: Patients in the topical vancomycin intervention group will receive 1 cc of vancomycin with a concentration of 100 mg/ml or 200 mg/ml based on Scourefont. Control group: none
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Dr. Sheikh Mashhad
Full name of responsible person
Fatemeh Saberi
Street address
Dr. Sheikh Hospital, Dr. Sheikh Street 3, Motahari Street , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Email
f.saberi.73@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Saberi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 468, Dehkhoda 15 Ave, Piroozi 15 Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177748153
Phone
+98 51 3878 4051
Email
f.saberi.73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Saberi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 468, Dehkhoda 15 Ave, Piroozi 15 Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177748153
Phone
+98 51 3878 4051
Email
f.saberi.73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Saberi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 468, Dehkhoda 15 Ave, Piroozi 15 Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177748153
Phone
+98 51 3878 4051
Email
f.saberi.73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available