Aim of this study is Ampicillin-sulbactam basecompared Colistin Basefor the treatment of acintobacter resistant to carbapenems in ventilator associated pneumonia .
Design
This study is clinical trial and double blind. patients will be divided in 2 groups by simple randomization.Groups are parallel.The number of patients is 66.
Settings and conduct
Patients with ventilator associated pneumonia in Valiasr hospital in Arak will enter this study. This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria:Ages over 16 years, ventilator-induced pneumonia with carbapenem-producing acinetobacter
Exclusion criteria:Failure to complete the course of treatment and discontinuation of treatment (due to drug complications and death, etc.), dissatisfaction
Intervention groups
Intervention group 1: Cholestine plus Carbapenem is prescribed in doses based on renal clearance and milligram in kilogram and converted to millions of units intravenously. We inject 500 gram Imipenem every 6 hours and meropenem 1 gram every 8 hours.
Intervention group 2:We inject Ampicillin / sulbactam and Carbapenem. We inject 9 grams of ampicillin / sulbactam three times daily, which can be adjusted based on renal clearance.
Main outcome variables
White blood cell count, erythrocyte sedimentation rate, culture of lung secretions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N126
Registration date:2019-12-17, 1398/09/26
Registration timing:retrospective
Last update:2019-12-17, 1398/09/26
Update count:0
Registration date
2019-12-17, 1398/09/26
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ampicillin-sulbactam basecompared Colistin Basefor the treatment of acintobacter resistant to carbapenems in ventilator associated pneumonia
Public title
Ampicillin-sulbactam basecompared Colistin Basefor the treatment of acintobacter resistant to carbapenems in ventilator associated pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages over 16 years
Ventilator-induced pneumonia with carbapenem-producing acinetobacter
Exclusion criteria:
Failure to complete the course of treatment and discontinuation of treatment (due to drug complications and death, etc.)
Dissatisfaction
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.In order to blind in two groups, the syringe covered with white paper on which they are written A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-06-17, 1397/03/27
Ethics committee reference number
IR.ARAKMU.REC.1397.089
Health conditions studied
1
Description of health condition studied
ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
White blood cell count
Timepoint
First study, third day, seventh day and 14th day
Method of measurement
Blood test
2
Description
erythrocyte sedimentation rate
Timepoint
First study, third day, seventh day and 14th day
Method of measurement
Blood test
3
Description
Culture of lung secretions
Timepoint
First study, third day, seventh day and 14th day
Method of measurement
Culture of lung secretions test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cholestine plus Carbapenem is prescribed in doses based on renal clearance and milligram in kilogram and converted to millions of units intravenously. We inject 500 gram Imipenem every 6 hours and meropenem 1 gram every 8 hours.
Category
Treatment - Drugs
2
Description
Intervention group: We inject Ampicillin / sulbactam and Carbapenem. We inject 9 grams of ampicillin / sulbactam three times daily, which can be adjusted based on renal clearance.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Masoumeh Sofian
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3645
Fax
+98 86 3222 2003
Email
sofian@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?