Evaluation of addition of Dexamethason to Antibiothic treatment in case of Septic Arthritis
Design
All patients will be prescribed Oxazepam 10 mg one hour before bedtime for comfortable sleep at night. In the first group, in addition to standard treatment (Vancomycin 1 g every 12 hours with Ceftazidime 1.5 g every 8 hours), the patient was given an 8-mg Dexamethasone ampoule every 8 hours for 4 days. In the second group, in addition to standard treatment, placebo will be prescribed (distilled water). Clinical and paraclinical signs of patients will be measured at the time of admission and at day 2, day 4 of discharge.
Settings and conduct
All people between the ages of 12 and 90 years who have had a history of recent Corticosteroid use, uncontrolled Diabetes and hypertension of other arthritis (rheumatoid arthritis) will go to Bou Ali Hospital in Qazvin.
Of the 146 enrolled, 73 received Dexamethasone along with Antibiotics, and 73 received only Antibiotics.
Participants/Inclusion and exclusion criteria
This study will include all people aged 12 to 90 years. Patients with no history of hypertension, uncontrolled Diabetes and recent Corticosteroid use, Immunodeficiency, Rheumatoid Arthritis and other Autoimmune Diseases that cause joint involvement.
Intervention groups
In the intervention group Dexamethasone 8 mg IV every 8 Hours for 4 Days
Main outcome variables
Duration of hospitalization
Duration of Symptoms
Duration of reduction of paraclinical parameters
General information
Reason for update
Acronym
DSA
IRCT registration information
IRCT registration number:IRCT20190903044679N1
Registration date:2019-12-19, 1398/09/28
Registration timing:registered_while_recruiting
Last update:2019-12-19, 1398/09/28
Update count:0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
Amin Karampour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 2230
Email address
a.karampour@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of addition of Dexamethason to Antibiothic treatment in case of Septic Arthritis
Public title
The effect of Dexamethasone in the treatment of Septic Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age>12 and Age<90
Exclusion criteria:
HTN
Poor control Diabet Melitius
Recent history of Corticosteroid use
Immunodeficiency
RA
Other Autoimmune Diseases that cause joint involvement
Age
From 12 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was randomly removed from the container containing a total of 146 entries including 73 A and 73 B and, as a result, placed the patient in group A or B.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both the researcher and the patient are not aware of Dexamethasone Injections
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin , Shahid Bahonar Boulevard,
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Approval date
2019-08-11, 1398/05/20
Ethics committee reference number
IR.QUMS.REC.1398.103
Health conditions studied
1
Description of health condition studied
Pyogenic arthritis
ICD-10 code
M00
ICD-10 code description
Pyogenic arthritis
Primary outcomes
1
Description
Duration of treatment
Timepoint
Daily
Method of measurement
Depending on the length of hospital stay
2
Description
The time it takes for CRP to normalize
Timepoint
Every three days
Method of measurement
Quantity
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention group: 8mg Dexamethasone ampoule will be given every 4 hours for 4 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali hospital
Full name of responsible person
Amin Karampour
Street address
Buali st
City
Ghazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 9049
Fax
+98 28 3332 6033
Email
boali.hospital@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amin Karampour
Street address
Qazvin, Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Ghazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Amin Karampour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Bou Ali Ave, Bou Ali Sina Medical Center
City
Ghazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 9049
Email
a.karampour@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amin Karampour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Bou Ali Ave, Bou Ali Sina Medical Center
City
Ghazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 9049
Email
a.karampour@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amin Karampour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Bou Ali Ave, Bou Ali Sina Medical Center
City
Ghazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 9049
Email
a.karampour@qums.ac.ir
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