The aim of this study was to compare the additive therapy of dexamethasone to placebo (both with antibiotic) in the treatment of septic arthritis. Material and methods: a randomized double-blind placebo-controlled trial study, 54 patients with septic arthritis that aged above 6 months and septic arthritis diagnosed with clinical and laboratory data were recruited. For diagnosis all involved joints aspirated and joints fluid and blood sample send to laboratory. Inclusion criteria : age above 6 months and patient with septic arthritis from first time; exclusion criteria : history of immunosuppressive disease or leukemia; history of systemic disease; use of antibiotic therapy before culture; use of systemic corticosteroid before disease; history of systemic inflammatory disease such as rheumatoid arthritis. Then patient will be divided to two groups ; one group receives antibiotic therapy administrates along with intravenous dexamethasone 0.15 mg/kg every 6 hours for 4 day and other group receives antibiotic therapy administrates along with intravenous placebo and two groups. Comparing for clinical and laboratory parameter & length of hospital stay and late sequels clinical parameter consists of fever, warm, limitation of motion and function in any joint. Laboratory parameter consist of WBC/cc, ESR ,CRP .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112011014N1
Registration date:2013-11-20, 1392/08/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-20, 1392/08/29
Registrant information
Name
Ali Mosapour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1223 5463
Email address
mosapour.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-07-17, 1391/04/27
Expected recruitment end date
2013-05-17, 1392/02/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparaing the effect of dexamethasone therapy versus placebo in septic arthritis treatment
Public title
the effect of dexamethasone therapy in septic arthritis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age above 6 months; patient with septic arthritis from first time. Exclusion criteria: history of immunosuppressive disease or leukemia; history of systemic disease; use of antibiotic therapy before culture; use of systemic corticosteroid before diseas; history of systemic inflamatory disease such as rheumatoid arthritis.
Age
From 1 year old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz
City
Ahvaz
Postal code
Approval date
2012-07-16, 1391/04/26
Ethics committee reference number
ETH568
Health conditions studied
1
Description of health condition studied
Septic arthritis
ICD-10 code
M00
ICD-10 code description
Pyogenic arthritis
Primary outcomes
1
Description
duration of teratment
Timepoint
daily
Method of measurement
number day stay in hospital
Secondary outcomes
1
Description
number of day that need CRPbecom normal
Timepoint
every three day
Method of measurement
from+ to+++++
Intervention groups
1
Description
15 cc/kg
Category
Treatment - Drugs
2
Description
Injected or not injected with dexamethasone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomaini hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghihi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hamidreza Arti
Position
Orthopaedic faculty of Ajums
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1322 5463
Fax
Email
hamidrezaarti@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hamidreza Arti
Position
Associated professor of orthopaedci surgery Ahvaz Jundishapur University Of Medical Sciences
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1322 5463
Fax
Email
hamidrezaarti@gmail.con
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali mousapour
Position
Orthopaedci resident
Other areas of specialty/work
Street address
Orthopaedci department of emam khomaini hospital
City
Ahvaz
Postal code
Phone
+61 12235463
Fax
Email
mousapourali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)