1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
07 Nov 2022
Comparative clinical trial of an evidence based and clinical pharmacist- recommended treatment protocol for the antimicrobial therapy of
aspiration pneumonia in opioid overdosed patients with the current treatment practice in the poisonings referral University hospital of Khorshid
Protocol summary
Study aim
Comparative clinical trial of an evidence-based and clinical pharmacist-recommended treatment protocol for the antimicrobial therapy of aspiration pneumonia -in opioid overdosed patients- with the current treatment practice in the poisonings referral University hospital of Khorshid
Design
Two parallel group randomized clinical trial Settings and conduct
Khorshid Hospital of Isfahan - Toxicology Ward Participants/Inclusion and exclusion criteria
ﯽﺴﯿﻠﮕﻧا - یزﺎﺳ ﯽﻓدﺎﺼﺗ زا ﻞﺒﻗ ﻪﻌﻟﺎﻄﻣ ﻪﺑ دورو مﺪﻋ هﺪﻤﻋ ﻂﯾاﺮﺷ Inclusion criteria: -patients older than 18 years old - Opioid intoxication -Having Aspiration pneumonia Exclusion criteria: -treatment with antibiotics and immunosuppressive drugs within two weeks before hospitalization -weman with pregnancy or breastfeeding -Patients with known allergic drug used in this study - Patients with hospital-acquired aspiration pneumonia - Patients with lung abscess or empyema
Intervention groups
Control group: Patients receiving ceftriaxone + clindamycin Case group: Patients receiving Ampicillin/sulbactam
Main outcome variables
Mortality,Relative improvement, Complete Improvement
General information
Reason for update Acronym
IRCT registration information
IRCT registration number: IRCT20090808002306N5
Registration date: 2019-11-30, 1398/09/09 Registration timing: registered_while_recruiting
Last update: 2019-11-30, 1398/09/09 Update count: 0
Registration date 2019-11-30, 1398/09/09 Registrant information
Name
Ali Mohammad Sabzghabaee Name of organization / entity
Isfahan university of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 31 3792 7070 Email address
sabzghaba@pharm.mui.ac.ir Recruitment status
Recruitment complete Funding source
Expected recruitment start date 2019-11-09, 1398/08/18
Expected recruitment end date 2020-11-08, 1399/08/18 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
2 Comparative clinical trial of an evidence based and
clinical pharmacist-recommended treatment protocol for the antimicrobial therapy of aspiration pneumonia in opioid overdosed patients with the current treatment practice in the poisonings referral University hospital of Khorshid
Public title
"The efficacy of recommended treatment protocol for the antimicrobial therapy of aspiration pneumonia in opioid overdosed patients"
Purpose Treatment
Inclusion/Exclusion criteria Inclusion criteria:
Patients older than 18 years old Opioid Intoxication Having aspiration pneumonia
Exclusion criteria:
treatment with antibiotics and immunosuppressive drugs within two weeks before hospitalization Patients with hospital-acquired aspiration pneumonia Patients with known allergic drug used in this study Patients with lung abscess or empyema weman with lung pregnancy or breastfeeding
Age
From 18 years old Gender
Both Phase
3
Groups that have been masked No information
Sample size
Target sample size: 80
Randomization (investigator's opinion) Randomized
Randomization description
Patients with inclusion criteria will be randomly assigned to two groups of case and control using Research randomizer software
Blinding (investigator's opinion) Not blinded
Blinding description Placebo
Not used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biomedical Research
Street address
Headquarters of Ministry of Health and Medical Education,Simaye Iran Ave,Ghods
Township(West),Tehran City
tehran Province Isfehan Postal code
...
Approval date
2019-11-08, 1398/08/17
Ethics committee reference number IR.MUI.RESEARCH.REC.1398.432
Health conditions studied
1
Description of health condition studied Aspiration pneumonia
ICD-10 code J18.1
ICD-10 code description
Lobar pneumonia, unspecified organism
Primary outcomes
1
Description Mortality Timepoint
The Seventh day intervention Method of measurement
Observation
2
Description
Relative Improvement Timepoint
The third Day of Intervention Method of measurement
Clinical and laboratory Monitoring
3
Description
complete Improvement Timepoint
The third Day of Intervention Method of measurement
Clinical and laboratory Monitoring
Secondary outcomes empty
Intervention groups
3
1
Description
Control group:Patients receiving ceftriaxone + clindamycin
Category
Treatment - Drugs
2
Description
Case group:Patients receiving Ampicillin/Sulbactam Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poisonings Referral University hospital of Khorshid Full name of responsible person
Ali mohammad sabzghabaee Street address
Poisonings Referral University hospital of Khorshid,Ostandari Ave,Isfahan
City Isfahan Province
Isfehan Postal code
...
Phone
+98 31 3222 2127 Email
sabzghaba@gmail.com
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Esfahan University of Medical Sciences Full name of responsible person
ali mohammad sabzghabaee Street address
Isfahan university of Medical science,Hezarjerib Ave,Isfahan
City Isfahan Province
Isfehan Postal code
....
Phone
+98 31 3792 7070 Email
sabzghaba@gmail.com Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences Full name of responsible person
Seyed mohammadreza tabatabaei Position
Clinical pharmacy Resident Latest degree
Medical doctor
Other areas of specialty/work Medical Pharmacy
Street address
Isfahan university of Medical science,Hezarjerib Ave,Isfahan
City Isfahan Province
Isfehan Postal code
...
Phone ...
mohamadtabatabaei1382@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences Full name of responsible person
Seyed Mohammadreza Tabatabaei Position
Clinical Pharmacy Resident Latest degree
Medical doctor
Other areas of specialty/work Medical Pharmacy
Street address
Isfahan university of Medical science,Hezarjerib Ave,Isfahan
City
4 Isfahan
Province Isfehan Postal code
...
Phone ...
mohamadtabatabaei1382@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences Full name of responsible person
Seyyed Mohammadreza Tabatabaei Position
Clinical Pharmacy Resident Latest degree
Medical doctor
Other areas of specialty/work Medical Pharmacy
Street address
Isfahan university of Medical science,Hezarjerib Ave,Isfahan
City Isfahan
Province Isfehan Postal code
...
Phone ...
mohamadtabatabaei1382@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 Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report Not applicable Analytic Code
Not applicable Data Dictionary Not applicable
